CSL Behring

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Responsibilities: The Director, Global Stakeholder Advocacy and Public Affairs leads the development and execution of global strategies to build CSL Behring's leadership profile and impact with key patient and other non-government stakeholders, with a focus on enabling the success of our mid- to late-stage development assets across our Therapeutic Areas of Immunology; Hematology; Transplant; Cardiovascular and Metabolic; and Respiratory. Lead analysis of stakeholder landscape in key therapeutic areas relevant to CSL Behring mid- to late-stage pipeline to identify and assess partnership opportunities Develop strategies to build CSL Behring profile and impact with key patient and other non-government stakeholders relevant to the success of our portfolio; collaborate with regional and country organizations to implement identified strategies Lead process to increase internal cross-functional participation in, and transparency of, CSL Behring activities and relationships with key patient and other non-government stakeholders, to enable strategic alignment, optimization of investments, and tracking of outcomes Lead development of external public affairs content to drive CSL Behring leadership and policy and political priorities, and to enable successful advocacy in key geographies Lead internal communication strategies to raise organizational awareness of GHPEA and its work, and enhance connectivity to key global and regional teams. Qualifications: Bachelor's degree; J.D. or other relevant advanced degree preferred 10+ years' government affairs experience Proven ability in developing and executing strategies to build company profile and impact with patient and other non-government stakeholders in a global environment in collaboration with regional and country teams Experience designing and implementing partnerships with patient groups and other non-government stakeholders to drive success of pipeline assets from development through to commercialization Experience generating content to support public affairs engagement across multiple channels, including campaigns, advocacy messaging, social media, and policy briefings Experience developing internal communications content to increase cross-functional integration and collaboration and to inspire and motivate employees Comprehensive business knowledge Strong project management experience with cross functional teams Superior relationship building skills Advocacy experience with pharmaceutical/ biotech, trade associations or patient advocacy organizations Worker Type: Employee Worker Sub Type: Regular

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Purpose: Reporting to a Maintenance Manager / Supervisor, incumbent will be responsible for the maintenance of aseptic and non-aseptic process equipment (GMP & non-GMP) in the Bulk and Fill Finish, Packaging, labeling, and cartoning areas. Incumbent will engage in supporting manufacturing and the execution of maintenance tasks, with minimal supervision. Shift - Nights Hours- 6PM-6AM Follows the 2,2, 3 schedule - off every other weekend Level will be determined based on years of experience Major Accountabilities: Works closely with Quality, Engineering and Operations groups to ensure strict compliance with GMP guidelines at all times, specifically to ensure that the equipment is maintained in GMP compliance. Maintains and performs corrective, preventative maintenance on aseptic and non-aseptic manufacturing equipment for in GMP & non-GMP systems. Maintains and provides recommendations for spare parts and PM procedures for equipment. Supports other departments/areas to troubleshoot, test, repair, and optimize, equipment. Participates in the continuous improvement efforts within the site Maintenance Program (including reliability). Responsible to respond to alarms for assigned equipment/areas. Executes maintenance work for various customers with minimal interruptions. Works with contract service providers and support contractors executing maintenance activities. Provides support for start-up, commissioning and turnover of new systems in assigned area. Uses tools and software (CMMS, PAS, Pi, PLCs, ETOPS, SAP) required to resolve equipment and process issues within all technical competencies. Assists other technicians and associates. Minimum Requirements: High school diploma or Equivalent required. Minimum of 1 year relevant industry experience or an associate's degree in relevant technical discipline with 2+ years of experience OR equivalent. Strong desire experience with trouble-shooting pharmaceutical manufacturing process problems (e.g., centrifuges, pressure test failures, electrical, autoclaves, utilities, clean steam, filling/packaging) Experience and knowledge of maintenance principles within a cGMP Biotechnology / Pharmaceutical manufacturing environment. Knowledge of DCS, PLC, and/or Building Automation Systems (BAS) control systems. Proven knowledge of a Computerized Maintenance Management System (CMMS). Ability to problem solve and troubleshoot systems in an industrial environment required Ability to plan and organize tasks. Interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Purpose: Responsible for providing quality system support to primary and secondary manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC. Major Accountabilities: • Owns deviations and writes product impact assessments. • Leads cross functional investigation teams in root cause analysis • Creates and executes CAPA plans to reduce the likelihood of reoccurrence. • Writes SOPs and batch records to support expansion activities • Issues SOPs and Batch Records to the production floor • Owns change controls including site wide change controls. • Writes Biological Product Deviation Report for submission to the FDA. • Performs Product Technical Compliant and Adverse Event investigations. • Provides technical support with multiple unit operations. Identifies solutions to address technical problems. • Writes technical training material for manufacturing processes. Minimum Qualifications • Bachelor's degree in Science or Engineering or equivalent industry experience • Direct experience within a cGMP environment preferred • Experience with deviation investigations and root cause analysis preferred • Experience with CAPA management and Change Controls preferred • Demonstrated troubleshooting skills • Strong organizational, planning and time management skills • Strong oral, written and interpersonal communication skills

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Position Purpose: Supervise the operation and maintenance of all plant utilities systems, clean utilities systems and bulk utilities systems at the Kankakee site. Applies a solid understanding of theories/practices around utility systems toward the effective operations and maintenance of the equipment. Ensures compliance with cGMPs and regulatory requirements. Responsible for 24/7 utilities operations and production support in the manufacturing plant. The position requires shift, weekend and holiday work. Responsibilities: Manage, administer and monitor the hourly personnel assigned to the Utilities Systems area to assure efficient and compliant operation and maintenance of all systems. Performs all scheduling activities to ensure appropriate coverage. Facilitate and verify appropriate training for all employees on the shift (including but not limited to cGMPs, job skills, safety, etc.) is up to date. Performs training of direct reports, contractors, and consultants. Responsible for handing out disciplinary action when required. Schedules system PM's and coordinates maintenance activities for equipment while minimizing impact on production schedules. Coordinate, oversee and manage contractors as needed to meet the responsibilities of the department. Responsible and accountable to maintain equipment in sound condition, report deficiencies and keep the equipment in the assigned area operating in an effective and compliant manner. Maintain the area inspection ready at all times. Collects and monitors data to ensure a timely and accurate response to system problems. Elevates cGMP related issues to management and Quality Assurance. Ensure compliance with cGMPs and regulatory requirements; provides timely notification to our customers on issues, their causes, duration, and resolution. Troubleshoots and coordinates efforts to keep systems running within defined parameters. Key support personnel on equipment failure investigations to ensure timely resolution of any issues thus assuring a continuous supply of utilities and state of compliance with all applicable standards, methods, procedures, licenses and regulations Orders supplies and materials required for repairs, PM's, safety, and housekeeping requirements, including but not limited to hazardous materials, caustic, nitrogen, ammonia, bulk salt, process alcohol, nitrogen, sodium hydroxide, HCL etc. Coordinates purchase and deliveries of these materials. Coordinates startup, shutdown, and isolation activities within the scope of plant projects, repairs, facility startups, etc. Review, author (where applicable) and revise training documents, SOP's, specifications, drawings, etc. Identify and support improvements that result in stable, reliable, and efficient operations. Track, monitor, assess and report operating and performance data that give insight and indication of the stability and robustness of equipment and systems on an ongoing and forward-looking basis. Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process. Provide necessary support to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life. Ability to communicate clearly, accurately, verbally and in writing with a strong understanding and knowledge of utilities and maintenance functions. Participate and provide support as system owners during regulatory audits. Communicates effectively with the Manager on issues and needs of the department. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in an Engineering related field. In lieu of a bachelor's degree an Associate's Degree with a minimum of 5 years of experience. In lieu of a degree a HS Diploma with a minimum of 7 years of supervisory experience in a related field in support of a pharmaceutical, biotechnology or FDA regulated facility. Experience: Experience working in a Union environment is preferred. Working knowledge of Process Safety Management and Hazardous Classification/Process Flammable Liquids is preferred. Boiler / Ammonia Certifications is preferred. Experience with Trackwise, LIMS, SAP, FMS, KAN MVE, Arriba, DCMS, GDRS, eTime, Plateau preferred. Knowledge of USP, cGMPs, European Regulatory requirements a plus. Experience working in a GMP controlled environment preferred Pharmaceutical Industry experience preferred. Strong Communication skills Ability to clearly communicate, both verbally and in writing, to all levels of the organization Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership Experience working in a Lean or Value Stream environment Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. "Hands-on" approach in support of manufacturing and facilities equipment. Must work and interact effectively and professionally with others. Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Competencies: Drives Results Customer Focus Conflict Management Timely Decision Making Time Management Cross cultural sensitivity Demonstrating CSL Values

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the clean utility distribution systems that include WFI, RO, Purified Water, Clean Steam and Process Gases with knowledge of associated plant utilities. Experience with other Plant Utilities (Boilers, Chillers, Cooling Towers, etc.) is a plus. The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support. Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the clean utility systems. Focus on providing support for existing and new utility systems. Review and make recommendations to management for clean utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning. Play an essential leadership role in the operation and troubleshooting of the clean utility systems. Serve as the clean utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems. Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives. Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures. Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation. Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. Participate in validation activities including review of IQ/OQ protocols, executions and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions. Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT's/SAT's, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications. Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup. Assist with developing predictive and preventative maintenance program for utility systems. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: Bachelor's Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Summary: The purpose of the position is to design, manage and coordinate toxicology programs for Seqirus. Work will include vendor selection, budgeting and monitoring of nonclinical safety studies, as well as interpretation, communication and reporting of the data generated. The incumbent will liaise closely with global cross-functional project teams and interact with regulatory authorities and external experts. The position will support the development of new products as well as life cycle management. Major Accountabilities: Develop toxicology strategies and provide toxicological expert support to research and development projects. Plan, monitor, analyze and report nonclinical pharmacology and toxicology studies conducted in collaboration with contract research organizations. Serve as functional representative on global project teams. Prepare nonclinical sections of regulatory submissions and respond to information requests. Manage and prepare toxicological risk assessments to support drug development and manufacturing. Evaluate data from extractable and leachable studies. Support manufacturing as required for changes in specifications, investigations into deviations and out-of-specification results. Participate in safety, quality, and project governance committees. Create nonclinical sections for Investigator's Brochures, Risk Management Plans, Product Information, Core Data Sheets, PSURs, DSURs, and other documents. Maintain a high level of awareness of scientific developments and the competitive environment to assist with strategic re-evaluation of ongoing programs. Actively establish and foster a high quality, global network with relevant experts internally and externally. Minimum Requirements: DVM or PhD or advanced degree in relevant field. DABT preferred. 8-10+ years experience in relevant industry experience required. Knowledge and relevant toxicology experience in development of biologics; Influenza and vaccines is preferred Knowledge and relevant experience with GxP regulations and implementation, and GLP as applicable to conduct of nonclinical studies. Knowledge and relevant experience with planning, monitoring, and interpreting nonclinical studies. Ability to manage interactions with external suppliers, and provide meaningful supervision of work sponsored by Seqirus and performed outside Seqirus Good demonstration of time and resource management, communication, and teamwork Ability to generate written reports or publications, to prepare and present data at cross-functional meetings and to internal and external stakeholders, and to demonstrate ownership, understanding, and accountability of assigned projects. Ability to critically review protocols and reports for nonclinical studies. Ability to perform risk assessments.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description Summary Hiring Location: Hidalgo, TX Ability to relocate within the states of Texas is REQUIRED after training is completed. Relocation assistance provided. Please note: This is a management trainee role. If hired, you will be in this position for approximately 6 to 7 months with the expectation that you will relocate with a promotion to an open Assistant Manager position. We have over 240+ centers across the country. In addition, you will be required to travel to our Pinellas Park, FL and/or Las Vegas, NV training sites for approximately 5 weeks, typically 1-2 weeks at a time. All candidates must be open to relocation (a company relocation program is included). You are encouraged to begin considering openings approximately 6 months after starting your training. After completion of training, travel will likely be required until you have secured an Assistant Manager position. If you have not applied and been promoted to an Assistant Manager position within a maximum of 9 months, CSL Plasma may assign you to a location with the requirement to relocate. Failure to relocate or failure to complete the training program successfully as scheduled may result in demotion or termination, at CSL Plasma's sole discretion. Job Description Responsibilities: 1. Collaborate with Center Management to ensure the day-to-day activities of Center operations are compliant with Standard Operating Procedures (SOP's) and applicable federal and local regulations. 2. Learn and understand all Center financial responsibilities including annual budgets and monthly financial analysis. Collaborate with Center Management in collecting and analyzing KPI's to support continuous improvement and meet Center established production goals. Learn to collect and analyze data to maintain and improve Center quality, efficiency and profitability. 3. Assist Center Management in ensuring Center is "inspection ready" at all times and customer requirements meet the safety of donors and employees including compliance with Occupational Safety and Health Administration (OSHA) and Environmental Health and Safety (EHS) regulations. 4. Learn and understand Company SOP's and applicable federal and local regulations, develop capabilities in performing nearly all staff tasks and duties at a proficiency level adequate for training and critiquing employees in the performance of those tasks and duties. 5. Develop skills to manage Center staff, including assisting Center Management with recruiting of staff, interviewing and selection of staff, and training of staff. Participate as witness when Center Management delivers staff counseling, including corrective actions and terminations, 45/90 day reviews and year-end performance appraisals. 6. Work with Management to understand efficient donor flow throughout the Center, identify problem areas, and advise Management of ER issues or escalated donor issues. 7. Under the supervision of the Assistant Quality Manager and/or ADOQ, participate in audits, investigations and deviations to determine root cause, correction/preventive actions and effectiveness checks. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues or deficiencies. 8. Collaborates with Assistant Quality Manager and/or ADOQ to develop quality programs in order to streamline center processes while maintaining compliance and quality. 9. Maintain a clean, efficient work environment. Learn inventory requirements; occasionally walk through facility to ensure operating supplies and inventory are available. 10. Ensure accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. 11. Familiarize with all marketing and advertising to ensure programs effectively deliver desired results. Make recommendations to Center Management as needed to improve effectiveness. 12. Develop excellent customer service skills. Provide a model of good customer service to employees. Communicate openly to customers. Learn to effectively resolve customer complaints and concerns. 13. Must be able to complete leadership development program and be able to relocate within 6-7 months. 14. May be cross-trained in other areas to meet the needs of the business. 15. Maintain confidentiality of all staff, donor and center information. 16. Perform other duties, as assigned, to support business needs. 17. A fully trained Management trainee who has completed all of their technical and leadership training may provide Quality coverage. Education Bachelor's degree preferred Equivalent combination of education and professional work experience required Experience If no degree, must have equivalent combination of education and professional work experience, including a minimum of 1-year supervisory, leadership experience responsible for overseeing the activities of others. Additional Skills Maintain company Technical Training certification Knowledge of ever-changing and complex government and industry regulations and ability to monitor compliance with these regulations Proficient in English Bilingual, Spanish a plus Working Conditions Shares information with internal contacts with common desire to reach a solution Ability to make decisions which have moderate impact on immediate work unit Must be able to see and speak with customers and observe equipment operation Occasionally perform tasks while standing and walking up to 100% of time Reach, bend, kneel and have high level of manual dexterity Occasionally be required to lift and carry up to 25 pounds Fast paced environment with frequent interruptions Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. Required to wear Personal Protective Equipment while performing specific tasks or in certain areas Required to work with the public who may be occasionally dissatisfied Attention to detail and ability to follow written and verbal directions required Frequently required to make and accept modifications to working processes and procedures as directed by SOP Overnight travel required up to 10% of the time #CB #CB CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Overview This is an opportunity to work within Quantitative Clinical Sciences and Reporting (QCSR), a group of scientists devoted to plan, execute, and interpret clinical data, studies, RWE, and contribute the quantitative aspect to corporate decision making. You will have opportunities to closely interact with colleagues from Biostatistics, Medical Writing, Epidemiology, Statistical Programming, Medical Affairs Support, and Patient-centric endpoint development. The group was formed to leverage synergies and promote the exploration and implementation of advanced analytical methods based on Artificial Intelligence. As part of the Biostatistics group within QCSR, you will contribute and build our capabilities in biostatistics both technically and operationally. Technically, you will have the opportunity to participate as we expand into new areas, such as artificial intelligence and machine learning, real world evidence and causality, applications of Bayesian statistics, advanced Adaptive Design, etc. Operationally, you can contribute to process improvement, organizational structure, automation of analysis, and other activities in addition to providing statistical leadership to the activities in your purview. You will play a key role in regulatory strategy and interactions. All of this is in an environment that is focused on personal development, teamwork, and mutual support. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Principal Biostatistician at CSL Behring will be working with the team dedicated to providing innovative therapies to enhance patients' lives with Respiratory diseases. The successful candidate will work in the clinical matrix team as a strategic, collaborative drug developer by providing statistical expertise to products at multiple phases to address unmet needs in the Respiratory therapeutic area. Responsibilities Apply statistical expertise to study design and contribute to protocol development Provide for project-wide planning of analyses; accountable for quality and timely delivery of interim and final results, and ad-hoc analyses Collaborate with, direct and monitor work of internal statistical programmers, study statisticians and/or CRO statistical teams under supervision. Support Biostatistics interactions with authorities Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculationsSupport or lead improvement initiatives within the department, organization and/or pharma industry Competencies: Advanced knowledge and training in applications of statistical methodologies Ability to collaboratively work in matrix environment and provide leadership in matrix environment Strong interpersonal and communication skills (verbal and written in English) Good working knowledge of SAS and/or R Experience with CROs (either managing a CRO, or having worked in a CRO) Qualifications Education: M.S. or PhD in Statistics or related field. Experience: PhD with 5 years of experience or M.S. with 8 years of experience in drug development

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description The Engineer is responsible for improving the reliability of equipment, utilities, critical systems and maintenance processes by applying the principles of Reliability Centered Maintenance. Apply Root Cause Analysis methodologies to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. Measure reliability performance and demonstrate success of improvements. Lead reliability driven actions that require independent and/or collaborative judgment. The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. Deliver compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews. Leads Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA). Lead Reliability Centered Maintenance Improvement (RCM) or other improvement projects in multiple areas. Develop the maintenance strategy, plans, SOPs, parts lists, BOMs and frequencies for new and modified equipment. Responsible for asset lifecycle management Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life. Ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions. Reviews engineering specifications and drawings, proposing design modifications to improve reliability within cost and other performance requirements Participate and provide support for audits. Lead, participate, and provide subject matter expertise in the design review and selection of new equipment. Perform the review, improvement and update of Maintenance SOPs, Parts Lists, BOMs and CMMS data integrity for existing equipment. Improve Equipment Parts Lists and BOMs accuracy in collaboration with MRO Data analysis of corrective work orders in CMMS and Quality Event Metrics to identify trends and identify areas of improvements Participate in FAT, Commissioning of new and modified equipment Perform functional equivalency assessment of spare parts. In collaboration with engineering, manufacturing, and maintenance personnel lead, perform or support troubleshooting of equipment. Participate and provide support for audits. Develop business case for improvements requiring investments and participate in capital planning for assigned area. Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations, which may include capacity, quality, cost, or regulatory compliance issues, by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA) and root cause failure analysis (RCFA), and failure reporting, analysis, and corrective action system (FRACAS) Supply engineering expertise in the specification, design, and construction of projects in accordance with plant design requirements, CSL standards, and regulatory requirements Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. Completes any other duties/responsibilities assigned by senior management. Education: • Bachelor's Degree in an Engineering related field, with 3+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility. • Certified Maintenance & Reliability Professional, preferred • Certified Reliability Engineer, preferred Experience: Experience working in a Union environment is preferred. Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma. Proficiency in Power BI is a plus Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership Experience working in a Lean or Value Stream environment Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's. Knowledge & experience in the design, implementation, operations and maintenance of utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA). Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry. Experience with Quality Management and Change Control Systems. Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision. "Hands-on" approach in managing support of manufacturing and facilities equipment. Knowledge of SAP maintenance management systems. Must work and interact effectively and professionally with others. Must have effective oral and written communication skills. Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols. Computer skills: MS Office Suite, MS Project, and AutoCAD.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Purpose: The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner. Shift: Nights Hours: 6pm-6am Schedule: 2,2,3 with every other weekend off Level will be determined by years of experience Major Accountabilities: Becomes trained on basic processes and equipment and serves as a hands-on resource in Production. Conducts all assigned activities in a safe and cGMP compliant manner. Cleaning, preparing, and sterilizing production equipment. Cleaning and disinfecting production rooms. Assembly, set-up, and disassembly of production equipment. Executing process steps according to defined SOPs and BPRs. Documenting activities in accordance with cGMPs. Handling biologically and chemically hazardous good. Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink.) Involved in Qualification and Validation activities. Identifying and communicating process issues. Involved in effective and timely completion of root cause investigations and CAPA. Works within a high performance teamwork environment and demonstrate Seqirus Values and Behaviors. Minimum Requirements: High school diploma/GED required, preferably coupled with Biotechnology coursework; bachelor's degree in science or engineering preferred. Minimum of 1 year of experience OR equivalent; experience in pharmaceutical, biotechnology, and/or sterile production environments is preferred. Basic knowledge of cGMP requirements preferred. Experience executing SOPs and documenting work preferred. Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Senior-level global leadership role that is accountable for the oversight and management of strategic planning and execution of Content across the CSL Group to support business objectives. The incumbent's responsibility will include ensuring one integrated global approach and execution plan in the management of content . In engaging with Communic ations Business Partners, h e/ s he is responsible for the ongoing development and execution of the company's Content Strategy and ensures Content resources and processes are standardize d , integrate d and optimize d. In leading the global multimedia Content Management Center of Excellence (COE), the incumbent ensures Content is within brand standards and is curated, produced , sequenced and distributed in a strategic, timely manner across CSL Group owned channels. The incumbent will be responsible for measuring the effectiveness of Content as well as leading the governance for content curation globally , including facilitating CSL Group Editorial Board. Additionally, the incumbent will have global oversight and management of strategic planning and execution of all external, leadership & employee communications, issues management and other functional communications supporting the global Information & Technology and Legal Group functions. The incumbent will be accountable for directing and executing corporate media relations in the northern hemisphere , including providing guidance to best position the Company among external stakeholders . He/she will assist the Chief Communications & Brand Officer with C EO media relations in the northern hemisphere. The incumbent will be responsible for global Employee Communications, developing and executing the Group's employee communications strategies and plans including overseeing CSL's multiple enterprise wide channels and ensuring employee communications enterprise wide processes are adhered to. The leader will be responsible for ensuring that all external, leadership and employee communications are aligned, coordinated and resources are leveraged globally within the scope of this responsibility. He/she also will ensur e governance of all global Communications processes, including documentation, staff training and process updates. Reporting to the CSL Group Chief Communications & Brand Officer, the incumbent will achieve these objectives by: Modeling CSL Values Serving as both strategist and executor Developing clear strategies and measurable execution plans Leading a cross-functional team for planning and execution. Developing and delivering leading-edge content for dissemination through multiple channels -- including "earned" media as well as CSL's "owned" multi-media publishing channels for both internal and external stakeholders/audiences. As a member of the Company's Global Communications Leadership Team (CLT), the incumbent actively collaborates with other senior communications leaders and colleagues around the world (especially other CLT members) to focus, coordinate and leverage as one integrated global communications function. RESPONSIBILITIES AND ACCOUNTABILITIES 1. Responsible for the overall global operations and business results delivered by the Content Management COE, Legal and Information & Technology Communications team., 2. Responsible for directing the global Content Management Center of Excellence. This includes developing its annual objectives to meet business needs, leveraging resources across the Enterprise and ensuring seamless delivery of content across the Enterprise. 3. Responsible for the global accuracy, appropriateness, and on-brand multimedia Content that focuses on supporting business objectives. This includes articles, videos, photos, podcasts, infographics, animations, and other associated content generated from the COE. 4. The incumbent will oversee CSL Group employee communications strategies and plans. This includes that CSL Group employee communications policies are adhered to globally. Responsible for optimizing, sequencing and delivering multimedia content of Enterprise-wide Employee Communications including CSL News, CSL NOW employee app 5. Manages corporate media relations in Northern Hemisphere. This includes developing and executing the annual Media Relations plan for Northern Hemisphere, fostering relationships with Tier 1 journalists and media outlets. 6. Global responsibility to ensure governance of all global Communications processes, including documentation, staff training and process updates. 7. Oversees third-party communications agencies in support of Company's business objectives, which includes leading agency selection and ensuring the company's global Brand Position is integrated and reflective in content and onboarding agencies. 8. Ensures Company's global Brand positioning is reflective in all content for both external and internal audiences. 9. Responsible for professional development and strengthening capabilities of direct team to enhance communications capabilities as part of global organization 10. As a member of the Company's Global Communications Leadership Team (CLT), the incumbent actively collaborates with other senior communications leaders and colleagues around the world (especially other CLT members) to focus, coordinate and leverage as one integrated global communications function. 11. Exceptional writing and editing skills to role model world-class Content Management 12. Lead specific team to ensure consistency and coordination of Communications across the CSL Group. 13. Ensures global Communications' processes and policies are established and adhered to globally. 14. Demonstrated ability to influence others, while fostering strong working relationships. 15. Responsible for professional development and strengthening capabilities of team 16. Coach and motivate team. 17. Focus on actively collaborating with key internal stakeholders particularly with GLG/senior leaders within his/her scope of responsibility and Global Communications Leadership Team - on the development and implementation of content management & global employee communications strategies and plans to achieve business objectives. 18. Demonstrated ability to be effective in a highly matrixed organization. 19. Champion best practices & execute across team through consistent engagement with global Communications team. Education • Bachelor's degree or equivalent in Marketing, Communications, Public Relations, Journalism or closely related field; MBA or Master's in communications a plus • Advanced, progressive professional development training is ideal. Experience • 12 years' communications experience including communications program/people management, in product or corporate communications/ public relations • Experience managing communications/teams within a global environment • Pharma/Biotech or similarly regulated environment experience desirable • Applied Science communications experience of 7+ years is highly desirable. • 3+ years digital communications experience. • Demonstrated experience in successfully working in a highly matrixed organization is a plus. #behring #LI-TD1

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Responsibilities: Provides technical review of design documents for automation systems Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom systems Independently leads small, engineering projects and change controls including concept, funding requests, and approvals Independently performs start-up and commissioning activities on assigned systems Troubleshoots complex equipment and/or automation related issues and develops sound engineering solutions to address identified problems for assigned systems, On-Call support required/Shift Support Recommends and implements performance and reliability improvements for assigned systems Leads complex deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Qualifications: Bachelor's degree in Engineering or related field required. Minimum 1+ years related industry experience required OR equivalent, including 1+ year(s)' experience in pharmaceutical/biotech operations Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) preferred Design experience or owners experience with automation or process systems Technical expertise in multiple systems/unit operations Experience in programming DeltaV, Allen-Bradley and/or Siemens automation systems for automation specific roles Strong communication skills with customers, design teams, contractors, and management Action oriented skills; ability to learn on the fly Good problem solving, technical learning, time management and prioritizing skills Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility * Level is dependent on experience and skill level.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Summary: The incumbent will be a member of the Manufacturing Sciences & Technology (MS&T) team supporting Bulk Manufacturing Operations. The MS&T function provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic improvements within the Bulk Cell culture and purification facility. Provide front line support of production and process-specific issues. This is a night shift role. Work Hours: 6PM-6AM, Schedule: 2-2-3 and includes every other weekend. Responsibilities: Provide support to manufacturing as the primary point of contact for technical and operational equipment/process issues. Troubleshoot and investigate equipment problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide technical information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision making. Maintain ownership of investigation of minor deviations, select major deviations and ensure timely closure through collaboration with Frontline QA. Maintain knowledge on the relationship between the process, the equipment, and the automation in the facility. Ensure that equipment works to its specification and capacity. Supervise and execute technical trials/ engineering run protocols and ad-hoc samples as needed to ensure successful completion and oversight of non-routine work Author and improve existing SOPs, and Work Instructions to improve processes and ensure safe and efficient operations. Provide Hyper-care coordination, implementation and support for new processes and significant changes, such as equipment upgrades or PPQ executions. Interface with maintenance, metrology, engineering, and quality to implement and update preventative maintenance plans, coordinate creation and execution of work orders, and ensure spare part quantities are appropriate. Liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution Learn, Understand and work within a matrix organization to drive performance. Active participation in Shift Change and hand off for all critical functions Be a strong partner to the shift supervisors and area managers. Qualifications: Bachelor degree in Engineering or equivalent in related field preferred or equivalent technical education and experience Minimum 3 years of experience working in the pharmaceutical/biotech and experience must be within cell culture/purification Experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments is preferred Strong understanding of engineering, equipment, and automation principles Strong mechanical aptitude or knowledge of electronic / mechanical equipment is required. High attention to detail in order to solve a range of routine and non-routine problems. * Level of role will be based on experience and skills.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description This position is responsible for performance of mRNA vaccine and adjuvanted protein vaccine formulation and characterization, to support vaccine discovery and development. Responsibilities: Performance of mRNA vaccine biophysical characterization and stability evaluation to support vaccine process development. Performance of mRNA vaccine and adjuvanted protein vaccine formulation to support vaccine preclinical development in animal models. Write experimental protocols and prepare internal reports. Maintain lab notebooks. Collaborate with project teams, present research results and contribute to technical advancements and publications. Maintain functional laboratory equipment and follow HSE regulation. Qualifications: Bachelors degree and e xperience with lipid nanoparticle characterization eg DLS-Zeta measurement, MALS, HPLC is required. Experience with formulation assays eg. SDS-PAGE, Nanodrop, Osmolarity and Endotoxin testing is preferred. Experience with lipid nanoparticle formulation is preferred. T he ability to generate accurate and reproducible results along with multi-tasking and working effectively in a fast-paced environment are required. Ability to work in teams and written/oral communication skills are required.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Position Purpose: Supervises the planning, scheduling, and completion of all Metrology work performed in assigned area to insure maximum uptime of equipment; oversees the activities of the technicians assigned to work areas in a manner to assure compliance with company, state, and federal agency guidelines; maintains planned work schedules and handles emergency work resulting from rendering of required services; manages work order system within area of responsibility; ensures necessary inventories of equipment and supplies are available. Responsibilities: Converts approved work schedules and emergency work requests into action oriented plans. Provide necessary materials and equipment needed to complete work in addition to assuring proper training, qualifications and GMP compliance. Defines the priorities of subordinates; provides evaluation of performance to subordinates. Administers bargaining unit agreement to maintain effective communication with represented contingent; applies company policies relating to progressive discipline, overtime, vacations, and LOAs. Investigates major instrument related problem areas and determines best course of action for resolution; frequently checks subordinates' work to assure quality and compliance with cGMPs. Directs all metrology functions to ensure compliance with appropriate sections of the CFR 21,600 and 200 series. Qualifications: Education: Bachelor's Degree in Engineering or related field preferred. In lieu of Bachelor's Degree, an Associate's Degree in a related field, Military certification, or other equivalent military certification. In lieu of a degree, a minimum of 10 years of service in the metrology/instrumentation field. Experience: Supervisory experience preferred. Special training in the calibration of pressure, temperature humidity, participate, voltage current, air samplers, dimensional, mechanical and physical devices. Experience in the use of Microsoft Desktop Systems a plus. Prefer experience in the pharmaceutical, food, or chemical processing industry. Competencies: Technical/functional skills, written communications, action oriented, and problem solving. Team oriented and proficiencies in calibration databases.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Summary: Reporting to the Director, Auditing and Inspections, this role is responsible for the aspects of GMP/GxP audits of vendors and internal sites and contract manufacturers, assessing compliance with regulatory and Seqirus requirements, to provide quality oversight and guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement at each of the manufacturing sites. The role is responsible for supporting strategic and quality compliance in all areas/functions of the business to ensure optimal inspection readiness, including appropriate preparation to enable a positive execution of any and all regulatory inspections and other third party audits (such as country specific import and export requirements for each site) and organising the inspection results together with corrective and preventative actions and ensuring that responses to authorities are provided in a timely manner. This individual is also responsible to support the harmonization, maintain and enforcing global audit strategy, processes, practices, and SOPs that are consistent across the manufacturing sites. A role will be located at each of the Seqirus sites, Parkville (AUS), Holly Springs (USA), or Liverpool (UK) or Maidenhead (UK). Major Accountabilities: Provides support for the preparation and execution of supplier and internal audits to verify compliance with global GMP regulations and corporate requirements Support to develop quality policies, procedures and standards governing and harmonizing of the global audit and inspection program for all Seqirus sites. Manage and assist to develop a global audit program and manage in collaboration with other sites the global audit schedule. Ensure that all audits and inspections are performed as per plan (either internally or by a 3rd party contractor). Assist to co-ordinate and execute supplier audits including inspections of CMOs/ Vendors/ distributors/ laboratories and service providers Participates and Support in Regulatory inspections at Seqirus sites Provide support and subject matter expertise to manufacturing sites, clinical sites and CMOs in preparation for regulatory inspections Participate in inspections to understand root causes behind quality issues Communicate identified quality issues globally to avoid repeated issues Support strategic resolutions to quality issues identified during regulatory or internal inspections. Track inspection responses and commitments to Regulatory agencies (Health authorities) across at assigned site. Maintain processes, procedures, and SOPs for auditing and inspections Partner with stakeholders to assist to develop and communicate innovative, compliant solutions using a risk based approach for internal and external inspections Support the global model for corporate audits (bi-annually) to identify weakness in cGMP systems. Further develop and train site personnel in principles of auditing and inspections. Ensure auditing and inspections teams are accredited, qualified to perform required inspections and adhere to processes and SOPs ensure inspectors are trained and accredited Maintain and update processes, procedures, and SOPs based on continuous improvement for conducting both internal and external audits Maintain and share knowledge of Regulations and Requirements Stay current and up to date with any regulations and requirements related to supplier management as well as industry/regulatory trends in this area Align with the Regulatory Intelligence and Knowledge Sharing team to ensure that new/enhanced requirements are communicated to the appropriate stakeholders, both internally and externally with vendors/partners Identify and/or create new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internally Work with site to design and implement standard requirements for external vendors/partners Provide Auditing and Inspections team leadership Provide leadership and guidance to the site Auditing and Inspections team to effectively execute on strategies and programs. Communicate assigned objectives and provide clear direction for execution and timelines to team. Recruit, retain, train and develop the team to legislative requirements for assigned Seqirus site Work in collaboration/ partnership with the Training department to further develop, implement and sustain GxP audit expertise in GMP/ GxP requirements, computer systems and computer software. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve. Minimum Qualifications: Bachelor's degree in science or engineering related discipline. Advanced degree a plus. Minimum 7+ years experience required; 10+ years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred. Must have expert GMP, Quality, and risk management knowledge. Experience authoring technical legal documents. Able to critically interpret results and generate technical conclusions consistent with Quality Risk principles. Experience in planning, organizing and executing effective audits/inspections Experience authoring audit reports, investigations, quality agreements, and risk assessments. Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc. Strong at conflict management and providing constructive feedback