Task Management Inc
Bloomingdale, Illinois
This position is intimately "hands-on" within the operation - on the shop floor, etc. The candidate must be willing to fix a quality organization, build structure and process, be knee deep in the details to turn it around, evaluate current team and determine way forward based on skills gaps, interact with customers on a regular basis reviewing deviations, reasons and corrective actions. Strong partner with operations to deliver throughput from a quality perspective. The Director of Quality provides leadership and accountability for the Quality Management Systems (QMS) in support of the Aerospace Division. The Director of Quality leads a diverse team of hourly and salaried quality associates to ensure safety, quality, delivery, cost and people development targets are met and continuously improved upon. The successful candidate is intimately hands-on with quality and operational partners, energetic, and success driven with deep technical expertise. They will have exemplary leadership, team building, problem solving, and time management skills and serve as a role model and leader to peers and associates. The Director of Quality will spend a significant amount of their time on the floor coaching and improving the way we work. The successful candidate will have a passion for developing people, improving quality processes and a desire to win. The Director of Quality is a CRITICAL player in the success of the business. Essential Duties and Responsibilities: Reporting to the CEO, the Director of Quality is responsible for the development and execution of a robust Quality strategy for the facility to drive results. Develop overall culture for continuous improvement in Quality. Promote an "end to end" focus on Lean & Quality from our Suppliers, through our Manufacturing Processes. Assure the requirements of our ISO 9001/AS9100, and other quality management systems, are maintained. Includes the quality reporting, corrective/preventive actions, Internal Auditing System and customer complaint tracking. Ensure all ISO 9001/AS9100 processes are followed, audited and documented showing impartial evidence of compliance. Drive implementation of the Quality Management System (QMS) throughout all site locations. Drive use of standardized lean & quality tools, share best practices, and benchmark world class companies to achieve a higher level of Operational Excellence. Evaluate organizational design and recommend improvements to optimize resources. Plan, assign and direct work, provide promotional and salary recommendations, coach, train and develop talent, and address complaints and resolve personnel problems to establish and maintain employee performance standards. Develop and execute the roadmap to achieve the long-term quality vision. Develop and execute Quality strategies in support of New Product Introduction (NPI) that satisfy near term demands of development programs and support long term vision of transitioning to full rate production. Analyze data, identify areas of opportunity, and implement kaizen activities or corrective actions to address Quality problem areas / opportunities. Communicate problem resolution to customers and senior management. Develop and maintain the Enterprise Quality Dashboard and score cards by Work Cell, Product Family and Customer. Develop Quality Plans in support of proposals and awarded programs. Manage Capital, Point of Control, and Expense budgets associated with Quality operations and improvements. Develop quality cost bids for proposals as well as initial baseline budgets and estimates to completes for awarded programs. Manage direct and indirect labor budgets. Coach, develop and mentor the operation and maintenance teams to create a high-performance culture with a continuous improvement mindset. Maintain a high level of presence and connectivity with employees at all levels of the organization. Support and develop a strong Environmental, Health, and Safety culture with the team by following all safety regulations and maintaining clean and orderly work areas. Qualifications and Education: Bachelor's Degree in a discipline related to Supply Chain Management, Operations, Engineering, Science, or Mathematics preferred. Implementation of AS9100 and NADCAP as needed for NDT, EDM, Milling and Grinding preferred. Minimum five (5) years' experience in a Senior level, lean and/or quality leadership role preferably in a DOD or Aerospace Environment. Six Sigma Green Belt, Black Belt certification preferred. Successful track record of talent development. Demonstrated track record of continuous improvement resulting in successful quality organization. Proficient in the use of Microsoft Office Suite to include Excel, Word, and Outlook and web interfaces. Strong computer skills, proficient with word processing, spreadsheet and presentation software, e-mail and meeting management software. Strong analytical skills and the ability to identify trends and establish proactive corrective actions. Must have demonstrated statistical analysis capabilities. An equivalent combination of education and work-related experience may be acceptable. Demonstrated ability for exceptional communication, collaboration, influence and driving change especially with engineering and manufacturing groups. TO APPLY: please email resumes to com - provided by Dice
This position is intimately "hands-on" within the operation - on the shop floor, etc. The candidate must be willing to fix a quality organization, build structure and process, be knee deep in the details to turn it around, evaluate current team and determine way forward based on skills gaps, interact with customers on a regular basis reviewing deviations, reasons and corrective actions. Strong partner with operations to deliver throughput from a quality perspective. The Director of Quality provides leadership and accountability for the Quality Management Systems (QMS) in support of the Aerospace Division. The Director of Quality leads a diverse team of hourly and salaried quality associates to ensure safety, quality, delivery, cost and people development targets are met and continuously improved upon. The successful candidate is intimately hands-on with quality and operational partners, energetic, and success driven with deep technical expertise. They will have exemplary leadership, team building, problem solving, and time management skills and serve as a role model and leader to peers and associates. The Director of Quality will spend a significant amount of their time on the floor coaching and improving the way we work. The successful candidate will have a passion for developing people, improving quality processes and a desire to win. The Director of Quality is a CRITICAL player in the success of the business. Essential Duties and Responsibilities: Reporting to the CEO, the Director of Quality is responsible for the development and execution of a robust Quality strategy for the facility to drive results. Develop overall culture for continuous improvement in Quality. Promote an "end to end" focus on Lean & Quality from our Suppliers, through our Manufacturing Processes. Assure the requirements of our ISO 9001/AS9100, and other quality management systems, are maintained. Includes the quality reporting, corrective/preventive actions, Internal Auditing System and customer complaint tracking. Ensure all ISO 9001/AS9100 processes are followed, audited and documented showing impartial evidence of compliance. Drive implementation of the Quality Management System (QMS) throughout all site locations. Drive use of standardized lean & quality tools, share best practices, and benchmark world class companies to achieve a higher level of Operational Excellence. Evaluate organizational design and recommend improvements to optimize resources. Plan, assign and direct work, provide promotional and salary recommendations, coach, train and develop talent, and address complaints and resolve personnel problems to establish and maintain employee performance standards. Develop and execute the roadmap to achieve the long-term quality vision. Develop and execute Quality strategies in support of New Product Introduction (NPI) that satisfy near term demands of development programs and support long term vision of transitioning to full rate production. Analyze data, identify areas of opportunity, and implement kaizen activities or corrective actions to address Quality problem areas / opportunities. Communicate problem resolution to customers and senior management. Develop and maintain the Enterprise Quality Dashboard and score cards by Work Cell, Product Family and Customer. Develop Quality Plans in support of proposals and awarded programs. Manage Capital, Point of Control, and Expense budgets associated with Quality operations and improvements. Develop quality cost bids for proposals as well as initial baseline budgets and estimates to completes for awarded programs. Manage direct and indirect labor budgets. Coach, develop and mentor the operation and maintenance teams to create a high-performance culture with a continuous improvement mindset. Maintain a high level of presence and connectivity with employees at all levels of the organization. Support and develop a strong Environmental, Health, and Safety culture with the team by following all safety regulations and maintaining clean and orderly work areas. Qualifications and Education: Bachelor's Degree in a discipline related to Supply Chain Management, Operations, Engineering, Science, or Mathematics preferred. Implementation of AS9100 and NADCAP as needed for NDT, EDM, Milling and Grinding preferred. Minimum five (5) years' experience in a Senior level, lean and/or quality leadership role preferably in a DOD or Aerospace Environment. Six Sigma Green Belt, Black Belt certification preferred. Successful track record of talent development. Demonstrated track record of continuous improvement resulting in successful quality organization. Proficient in the use of Microsoft Office Suite to include Excel, Word, and Outlook and web interfaces. Strong computer skills, proficient with word processing, spreadsheet and presentation software, e-mail and meeting management software. Strong analytical skills and the ability to identify trends and establish proactive corrective actions. Must have demonstrated statistical analysis capabilities. An equivalent combination of education and work-related experience may be acceptable. Demonstrated ability for exceptional communication, collaboration, influence and driving change especially with engineering and manufacturing groups. TO APPLY: please email resumes to com - provided by Dice
Amgen
Cambridge, Massachusetts
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.