58 jobs found

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's Oncology Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require a CDx for drug registration or for any project with CDPs containing multiple registrational clinical trials and are extensively exploring the predictive nature of potential CDx assays.Leads CDx project teams for the diagnostic, in full alignment with Global Project Teams (GPT) covering all areas from CDx assay development through CDx approval and launch. Creates the CDx development strategy, including partner evaluation and selection for a registrational phase project.Manages CDx development activities and deliverables in collaboration with diagnostic partner across all clinical trials within the project, including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission strategies.May represent DS in various Health Authority interactions for the drug trials or for approval of CDx.Keeps abreast of regulatory and policy updates in the external environment and understands the competitive landscape.Proactively shifts CDx strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, and in support of pre-launch, launch and LCM activities as necessary. Direct line management responsibility including developing and mentoring of Managers, Associate Directors and Directors. May serve on CDx department extended leadership team. Qualifications: (What are the minimum requirements for the position?) Education: PhD, MD or PharmD - minimum of 12 years' experience or MS - minimum of 15 years of experience or BS/BA - minimum of 19 years of experience required Experience: Demonstrated track record of success working on multidisciplinary, international pharmaceutical development teams Experience with CDx regulatory submissions to the FDA and other health authorities globally. At least 4 years of companion diagnostic development experience within a pharmaceutical company. At least 2 years of experience managing direct reports. Competencies: Ability to lead in a highly collaborative global environment with stakeholders from multiple functional areas Strong strategic leadership skills with an ability to define, prioritize and balance team responsibilities in accordance with business and team needs Strong interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams, both internal teams and alliance partner teams, and with all levels of management, including senior management, across various functions and locations Broad knowledge and understanding of established and new assay technologies.Ability to strategically think about how to incorporate new technologies into the drug development process. Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization. Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx members. Ability to influence without authority within the organization. Ability to inspire and to lead direct reports. Travel: Domestic and international may be required: 15% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $230,175.00 - $383,625.00Download Our Benefits Summary PDF

Description: Job Title: Associate Director / Director, Study Trial Master File (TMF) Location: Bala Cynwyd, PA Travel: Approximately 10% (domestic/international) Reports to: Chief Development Officer (initially) The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary We are seeking an experienced and detail-oriented Associate Director or Director to lead all aspects of Trial Master File (TMF) management for a single, global clinical trial. This TMF Owner will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF for a global study, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office. Job Responsibilities TMF Oversight & Compliance Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, consistency, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and evolving regulatory requirements. Lead the TMF plan and build study eTMF and ensure completeness accordingly Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements). Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary. Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial. Stay current with regulatory changes and industry best practices, translating them into actionable process improvements. Process Management & Quality Control Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance. Establish and monitor TMF performance metrics, monitoring them, and proactively identifying and addressing documentation gaps. Report on metrics, highlighting risks, driving remediation, and presenting continuous improvement strategies to senior leadership. Drive continuous improvement in TMF operations, including CAPAs and lessons learned. Travel domestically and internationally ( 10%) for vendor oversight, study team meetings, audits, or inspections. Cross-Functional Collaboration Work closely with clinical operations, regulatory affairs, quality assurance, and other internal stakeholders to support timely and accurate documentation filing. Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations. Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation. Manage and build strong partnerships with external vendors, CROs, and internal stakeholders to ensure consistent TMF standards, timely document flow, and adherence to project milestones. Manage third-party TMF vendor(s) involved in the trial, ensuring adherence to quality standards, timelines, and deliverables. Serve as the business owner of the eTMF system for the study, including oversight of configuration, access controls, and change management. Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices. Inspection Readiness & Regulatory Support Ensure the TMF is prepared for regulatory inspection at any point during the trial. Lead TMF reviews and remediation efforts in preparation for audits or inspections. Assist with audit response and CAPA development as needed. Other responsibilities Perform related duties as necessary or as assigned Requirements: Qualifications Minimum of 15+ years of relevant industry experience with a Bachelor's degree, or 10+ years with a postgraduate degree. Experience managing TMF for global clinical trials including direct vendor oversight Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms. Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations. Strong, practical knowledge of the DIA TMF Reference Model and its application within operational settings. Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities. Exceptional communication skills-able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams. Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines. Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment. Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model. Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI91f15ea60e7d-1581

POSITION SUMMARY The Assistant Director of International Student Programs plays a key role in supporting the Office of International Student Affairs (OISA) by fostering student success, belonging, and intercultural engagement. The Assistant Director develops creative, student-centered programming that addresses cultural adjustment, immigration compliance, and other unique needs of our global student body. The OISA supports approximately 350 degree-seeking international students and 60 alumni throughout their post-completion practical training authorization, and the College also hosts around 20 Exchange Visitors annually. This position leads several signature programs, including the Fischlowitz Travel Fellowship, Friends of International Students (which links students with a community host), a Cultural Attaché outreach program, the Gallery of Flags, and MOSAIC Magazine. They maintain the OISA s website and facilitate a creative social media presence for the office. They advise the International Student Organization, which coordinates two large student-led events: Food Bazaar and Cultural Evening. They broadly encourage student leadership by building partnerships and collaborative initiatives that advance Grinnell s international diversity and inclusion goals. The Assistant Director serves as a Designated School Official (DSO). They offer F-1 student advising on enrollment, travel, status maintenance, and employment eligibility. They vet and issue initial immigration documents, offer travel endorsements, and process SEVIS updates. This role also includes service on various campus committees as assigned, and regular engagement with colleagues in the Division of Student Affairs and related campus partners to ensure holistic support for international students. Key Responsibilities Office of International Student Affairs Staff Member (40%) Provide professional, culturally sensitive advising for international students, ensuring privacy, appropriate referrals, and student success. Coordinate OISA communications, including a weekly e-newsletter, social media presence, and relevant campus outreach. Manage annual programming (logistics, scheduling, supplies, reservations) and collaborate with Student Affairs and other relevant campus partners. Represent the OISA on campus committees and participate in professional development networks (e.g., NAFSA, ACM/GLCA). Student Programming and Belonging (40%) Lead signature programs including the Fischlowitz Travel Fellowship, Cultural Attaché Program, Friends of International Students, and MOSAIC magazine. Advise the International Student Organization (ISO) and help to support their major events like Food Bazaar and Cultural Evening. Develop creative programming and intercultural initiatives with campus and community partners. Coordinate activities for international students who remain on campus during break and vacation periods. Designated School Official & Regulatory Support (20%) Serve as a DSO for F-1 students, advising on enrollment, travel, employment eligibility, and maintaining visa status. Facilitate I-20 vetting and issuance, travel endorsements, and SEVIS compliance via the GrinnImmigration Portal (Terra Dotta ISS). Ensure compliance with record retention and assist with resources for non-resident tax obligations via Sprintax Returns. Stay current on federal regulations and institutional policies impacting F-1 visa holders. ABOUT GRINNELL COLLEGE Grinnell College is a top-ranking private liberal arts institution that values diversity, equity, inclusion, intellectual freedom, and social responsibility. We seek candidates that align with these values and have the ability and desire to advance our values and belonging within our community and the communities we engage in. Ideal candidates will be prepared to collaborate and contribute to the mission and values of the college across all constituencies.

The Portfolio Director is a key academic and strategic leader within the Global Academic and Learning Enterprise (GALE) at UMGC. Responsible for setting the vision, direction, and priorities for a portfolio of learning experiences within a specific disciplinary and industry domain, the Portfolio Director ensures alignment to workforce trends, employer needs, and academic innovation. This role curates a full spectrum of learning experiences-including degrees, certificates, micro-credentials, and workforce-based programs-and works in collaboration with cross-functional university teams to optimize learner outcomes, enhance access, and ensure career relevance. Positioned at the intersection of education and industry, the Portfolio Director is charged with ensuring high-quality, stackable, market-responsive learning experiences that support UMGC's commitment to serving diverse, global learners throughout their lifelong learning journey. Success in this role is defined by the ability to lead a high-performing, data-informed portfolio that delivers stackable, market-relevant learning experiences; cultivates meaningful collaboration across academic and operational units; and drives measurable improvements in learner access, engagement, and outcomes. Duties and Responsibilities: Establishes and leads the intellectual and strategic direction and priorities for the Finance and Economics portfolio of learning experiences, maintaining strong awareness of and alignment to required and emergent employer/industry knowledge, skills, abilities, and dispositions. Identifies and ensures stackability of the skills-based learning experiences in the portfolio, deliberately mapping pathways including non-credit, micro-credential, professional, and workforce development experiences through academic courses, certificates, and degrees. Develops relationships with industry and community partners, including employers, professional organizations, certification bodies, and other universities and community colleges to ensure curriculum alignment and emerging relevance. Remains connected to and conversant in national discussions about the post-secondary education landscape, learner outcomes, workforce needs, and educational innovations specifically in the disciplines and industries germane to their portfolio of learning experiences. Identifies new technologies, theories, and approaches within the Finance and Economics fields/disciplines to enhance learner preparation for the workforce and the quality of the learning experience. Innovates and collaborates with university stakeholders on ways to validate and credential diverse forms of prior learning and contributes to new credentialing models. Works with Product Management to evolve the portfolio based on labor market and learner demand, ensuring stackable, scalable, and timely offerings. Collaborates with departments and offices across the global university to deliver a best-in-class learner experience, including surrounding the learner in support from both academic and nonacademic vantage points, enhancing learner engagement, and resolving learner issues and grievances, leading to higher levels of learner success. Working collaboratively across the university, optimizes the quality and performance of learning experiences through collaborative, data-driven activities and initiatives to ensure a high-quality portfolio of learning experiences, including measures of learner satisfaction, engagement, learning, and the learner experience as drivers of learner success, persistence, retention, and completion. Monitors and assesses portfolio performance through data and analytics, identifying opportunities for improvement and innovation. Uses market and audience research for Product Management to assess portfolio performance in terms of the national post-secondary and employer markets and identify appropriate learning experiences to start, stop, and continue. With the support and collaboration of Student Affairs, identifies appropriate academic support services. With the support and collaboration of the Office of Community Engagement and Opportunity and other teams across the institution, monitors learner satisfaction, engagement, learning, success, persistence, retention, and completion by learner demographic groups with an explicit focus on eliminating achievement gaps and improving outcomes for learners from historically marginalized communities. Collaborates with key stakeholders (Integrative Learning Design (ILD) and the Center for Institutional Effectiveness (CIE in the use of assignment-, course-, faculty-, and program-level data to identify and initiate targeted and deliberate improvements to both the design and delivery of learning experiences. Partners with ILD to plan and convene Product Design Summits through which product vision, strategic direction, and alignment with employer/industry knowledge, skills, abilities, and dispositions are defined. Approves appropriate, industry leading SMEs to develop learning and curriculum content and collaborates with ILD in the revision of learning experiences, including course and program content, selection of learning resources, and design of learning assessments. Facilitates a global community of faculty, ensuring faculty are optimally prepared and supported to facilitate the learning experiences for which they are hired, to include maintaining fidelity to the curriculum while adding richness and value to the learning experience through the specific and deliberate inclusion of their applied, industry experiences Partners with the Faculty Affairs and Scheduling Team (FAST) to monitor teaching performance, provide coaching support, ensure alignment with instructional standards, and ensures that adjunct faculty provide a learning experience that meets learner needs, to include identifying and effectively addressing individual learner needs and issues, connecting learners with appropriate academic and social-emotional support services, and delivering personalized, timely, and substantive feedback and responses to learner assessments and questions. Convenes portfolio team meetings, maintains communications infrastructure (e.g., Program Hub, Course Announcements, SharePoint), and fosters a connected community of practice to ensure all faculty are abreast of changes in courses, program, and other learner experiences. Serves as national and international university spokesperson and point person for highly effective learner experience practices that result in learner acquisition of the skills and areas of study in their portfolio. May be required to teach, facilitate seminars, contribute to content and learning object development and curation, serve on committees, contribute to institutional initiatives, and perform other job-related duties as assigned. Competencies: Strategic academic leadership and cross-functional collaboration Deep knowledge of current and emerging workforce and education trends Understanding of the higher education landscape and its regulatory environment Data-informed decision-making and continuous improvement orientation Inclusive mindset and ability to build community across diverse and distributed teams and stakeholders Deep understanding of adult, online education best practices and emerging trends Excellent communication and stakeholder engagement skills Relentlessly curious about new ways to assess, certify, and credential learners and KSADs regardless of their origin Seeks out diverse perspectives and experiences of colleagues throughout the institution Willing and able to challenge the status quo Skills: Portfolio strategy and lifecycle management Learning pathway development Industry and labor market analysis Stakeholder relationship building (internal and external) Use of analytics platforms, dashboards, and qualitative data to monitor learner and faculty performance Key Collaborators: Vice President and Dean (Academic School): To align portfolio vision with school strategy, institutional goals, and performance expectations. Integrative Learning Design (ILD): To co-develop and revise high-quality, technology-enhanced learning experiences. Academic Administration: To ensure operational effectiveness, policy alignment, and strategic planning across academic units. Academic Pathways: To coordinate stackable learning experiences, optimize opportunities for credit for prior learning, and support seamless learner progression across credentials. Registrar: To align program and course structures with credit articulations and records processes. Portfolio Directors: To promote collaboration, share insights, and align interdisciplinary or cross-portfolio initiatives as a collegial community of practice. Global Collegiate Faculty: To ensure instructional alignment, course fidelity, and learner engagement across modalities and geographies. Partnerships/Corporate Learning Solutions: To co-create and customize pathways and programs in response to partner needs and evolving workforce trends. Product Management: To analyze labor market trends, assess program performance relative to market, and guide portfolio decisions. Faculty Affairs and Scheduling Team: To ensure faculty development, teaching quality, and instructional effectiveness across the portfolio . click apply for full job details

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities. Responsibilities: This individual will be the main point of contact and support all signal management activities. They will lead the safety signal governance and develop, or update associated policies, charter and procedures, as applicable. On a daily basis provide total oversight on the processes relating to the conduct of signal detection via the appropriate tool(s). Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents. When required, assist the product safety teams in the entering of key signal information into the appropriate tool. Advise teams on key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support tasks of change control, training material update, and end user support or process enhancement. In collaboration with the signal management head, this individual will determine the necessity and validity of change requests and when required, perform user acceptance training. Ability to answer all queries relating to the signal detection tool as well as troubleshoot issues and promptly identifying solution(s) to ensure compliance. Develop and deliver ad-hoc and periodic trainings to build organizational capability on the entire signal management process consisting of detection, evaluation, and if applicable, proposed actions (e.g., changes to product information and/or other risk minimization measures) as a result of a validated signal. This individual will be able to provide subject matter expertise to the GPTs on the processes relating to signal detection, investigation, evaluation, and tracking as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (e.g., disproportionality assessments). This individual will ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company's products. Provide oversight over compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines. Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. Controls and assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural documents (e.g. SOPs) as appropriate. Collaborate with cross-functional teams (e.g., Medical Safety, Regulatory Affairs, Epidemiology) to ensure benefit-risk integration to ensure signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy. Represents the CSPV department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required. Support audit and inspection readiness activities as a subject matter expert. This individual will be accountable for maintaining a state of inspection readiness and in turn, act as key representer of DS in inspections/audits (presentations of signal process, coordination of document requests) throughout the year. Additionally, this individual will be the lead in support of all corrective action/preventative action (CAPA) or process improvements for signal management. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: Bachelor's Degree Health care background or life science degree/Bachelors required PharmD preferred PhD preferred Experience: 4 or More Years 5-7 years of relevant experience in pharmacovigilance within the pharmaceutical industry required 4 or More Years At least 4 years of experience in PV signal detection required 1 or More Years 3 years of experience collaborating on global project teams required Experience with safety databases and signal detection platforms required Experience in global PV inspection and/or audits required Strong knowledge of global PV regulations and signal detection methodologies required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00Download Our Benefits Summary PDF

About this opportunity : As the Site Head of Quality Assurance, you will report to the VP of Quality and Regulatory Affairs. The role is responsible for leading and managing all QA functions at the Cincinnati site to ensure compliance with regulatory standards, internal quality policies, and customer expectations. This role plays a critical leadership function in establishing and maintaining a robust Quality Management System (QMS), driving continuous improvement, and supporting regulatory inspections and client audits. Key Job Responsibilities: Lead the Quality Assurance function across the manufacturing site with a focus on compliance, operational excellence, and customer satisfaction. Develop and implement QA strategies aligned with corporate quality objectives and regulatory expectations. Provide effective oversight of critical quality systems. Ensure timely completion of GMP staff training, thorough deviation/OOS investigations leading to root cause identification and effective CAPA, implementation of timely and effective changes, on-time material/in-process control/product testing, and lot disposition. Develop and present in site Quality Council and QMR quality metrics to monitor and analyze key parameters for quality compliance, operational quality, and continuous improvement. Act as a quality representative on the site's leadership team and contribute to cross-functional decision-making. Ensure site adherence to ICH, and global regulatory cGMP requirements (FDA, EMA, MHRA, etc.). Maintain readiness for inspections. Serve as the primary QA contact for regulatory inspections and client audits. Lead audit responses and CAPA implementation. Oversee supplier management, internal audit, Gemba Walk program, and Manufacturing QA activities to ensure site compliance. Collaborate with clients on QA-related matters, including product quality, audits, quality agreements, and investigations. Build and maintain strong relationships with client quality counterparts. Lead, mentor, and develop the QA team to ensure capability, performance, and career growth. Foster a quality culture that emphasizes integrity, compliance, collaboration, and continuous improvement. Required Skills/Abilities: Advanced scientific degree in Pharmacy, Chemistry, Biotechnology, or related life sciences discipline preferred, or bachelor's degree with significant relevant experience. Minimum of 12-15 years of experience in the pharmaceutical or biotech industry, with experience in CDMO preferred. At least 10 years of quality assurance experience, including a minimum of 5 years in a management role with direct site-level quality responsibility. Preferred experience in hosting regulatory inspections and supporting product PPQ and commercialization. Deep understanding of international regulations such as FDA 21CFR, EU EudraLex Vol 4, USP, EP, JP. Strong knowledge and experience implementing/enforcing ICH Q guidelines, and regulatory guidance documents related to process and computerized system validation. Strong critical thinking and decision-making skills. Excellent organizational, planning, and communication skills. Effective time management skills to support rapid business growth. Ability to lead, motivate, coach, and train team members and non-quality personnel effectively. Must be able to effectively interact with subordinates, customers, regulatory agencies, and peers to resolve problems and establish procedures. The annualized salary range for this position is $171,800.00 - $210,100.00.

The Portfolio Director is a key academic and strategic leader within the Global Academic and Learning Enterprise (GALE) at UMGC. Responsible for setting the vision, direction, and priorities for a portfolio of learning experiences within a specific disciplinary and industry domain, the Portfolio Director ensures alignment to workforce trends, employer needs, and academic innovation. This role curates a full spectrum of learning experiences-including degrees, certificates, micro-credentials, and workforce-based programs-and works in collaboration with cross-functional university teams to optimize learner outcomes, enhance access, and ensure career relevance. Positioned at the intersection of education and industry, the Portfolio Director is charged with ensuring high-quality, stackable, market-responsive learning experiences that support UMGC's commitment to serving diverse, global learners throughout their lifelong learning journey. Success in this role is defined by the ability to lead a high-performing, data-informed portfolio that delivers stackable, market-relevant learning experiences; cultivates meaningful collaboration across academic and operational units; and drives measurable improvements in learner access, engagement, and outcomes. Duties and Responsibilities: Establishes and leads the intellectual and strategic direction and priorities for the Finance and Economics portfolio of learning experiences, maintaining strong awareness of and alignment to required and emergent employer/industry knowledge, skills, abilities, and dispositions. Identifies and ensures stackability of the skills-based learning experiences in the portfolio, deliberately mapping pathways including non-credit, micro-credential, professional, and workforce development experiences through academic courses, certificates, and degrees. Develops relationships with industry and community partners, including employers, professional organizations, certification bodies, and other universities and community colleges to ensure curriculum alignment and emerging relevance. Remains connected to and conversant in national discussions about the post-secondary education landscape, learner outcomes, workforce needs, and educational innovations specifically in the disciplines and industries germane to their portfolio of learning experiences. Identifies new technologies, theories, and approaches within the Finance and Economics fields/disciplines to enhance learner preparation for the workforce and the quality of the learning experience. Innovates and collaborates with university stakeholders on ways to validate and credential diverse forms of prior learning and contributes to new credentialing models. Works with Product Management to evolve the portfolio based on labor market and learner demand, ensuring stackable, scalable, and timely offerings. Collaborates with departments and offices across the global university to deliver a best-in-class learner experience, including surrounding the learner in support from both academic and nonacademic vantage points, enhancing learner engagement, and resolving learner issues and grievances, leading to higher levels of learner success. Working collaboratively across the university, optimizes the quality and performance of learning experiences through collaborative, data-driven activities and initiatives to ensure a high-quality portfolio of learning experiences, including measures of learner satisfaction, engagement, learning, and the learner experience as drivers of learner success, persistence, retention, and completion. Monitors and assesses portfolio performance through data and analytics, identifying opportunities for improvement and innovation. Uses market and audience research for Product Management to assess portfolio performance in terms of the national post-secondary and employer markets and identify appropriate learning experiences to start, stop, and continue. With the support and collaboration of Student Affairs, identifies appropriate academic support services. With the support and collaboration of the Office of Community Engagement and Opportunity and other teams across the institution, monitors learner satisfaction, engagement, learning, success, persistence, retention, and completion by learner demographic groups with an explicit focus on eliminating achievement gaps and improving outcomes for learners from historically marginalized communities. Collaborates with key stakeholders (Integrative Learning Design (ILD) and the Center for Institutional Effectiveness (CIE in the use of assignment-, course-, faculty-, and program-level data to identify and initiate targeted and deliberate improvements to both the design and delivery of learning experiences. Partners with ILD to plan and convene Product Design Summits through which product vision, strategic direction, and alignment with employer/industry knowledge, skills, abilities, and dispositions are defined. Approves appropriate, industry leading SMEs to develop learning and curriculum content and collaborates with ILD in the revision of learning experiences, including course and program content, selection of learning resources, and design of learning assessments. Facilitates a global community of faculty, ensuring faculty are optimally prepared and supported to facilitate the learning experiences for which they are hired, to include maintaining fidelity to the curriculum while adding richness and value to the learning experience through the specific and deliberate inclusion of their applied, industry experiences Partners with the Faculty Affairs and Scheduling Team (FAST) to monitor teaching performance, provide coaching support, ensure alignment with instructional standards, and ensures that adjunct faculty provide a learning experience that meets learner needs, to include identifying and effectively addressing individual learner needs and issues, connecting learners with appropriate academic and social-emotional support services, and delivering personalized, timely, and substantive feedback and responses to learner assessments and questions. Convenes portfolio team meetings, maintains communications infrastructure (e.g., Program Hub, Course Announcements, SharePoint), and fosters a connected community of practice to ensure all faculty are abreast of changes in courses, program, and other learner experiences. Serves as national and international university spokesperson and point person for highly effective learner experience practices that result in learner acquisition of the skills and areas of study in their portfolio. May be required to teach, facilitate seminars, contribute to content and learning object development and curation, serve on committees, contribute to institutional initiatives, and perform other job-related duties as assigned. Competencies: Strategic academic leadership and cross-functional collaboration Deep knowledge of current and emerging workforce and education trends Understanding of the higher education landscape and its regulatory environment Data-informed decision-making and continuous improvement orientation Inclusive mindset and ability to build community across diverse and distributed teams and stakeholders Deep understanding of adult, online education best practices and emerging trends Excellent communication and stakeholder engagement skills Relentlessly curious about new ways to assess, certify, and credential learners and KSADs regardless of their origin Seeks out diverse perspectives and experiences of colleagues throughout the institution Willing and able to challenge the status quo Skills: Portfolio strategy and lifecycle management Learning pathway development Industry and labor market analysis Stakeholder relationship building (internal and external) Use of analytics platforms, dashboards, and qualitative data to monitor learner and faculty performance Key Collaborators: Vice President and Dean (Academic School): To align portfolio vision with school strategy, institutional goals, and performance expectations. Integrative Learning Design (ILD): To co-develop and revise high-quality, technology-enhanced learning experiences. Academic Administration: To ensure operational effectiveness, policy alignment, and strategic planning across academic units. Academic Pathways: To coordinate stackable learning experiences, optimize opportunities for credit for prior learning, and support seamless learner progression across credentials. Registrar: To align program and course structures with credit articulations and records processes. Portfolio Directors: To promote collaboration, share insights, and align interdisciplinary or cross-portfolio initiatives as a collegial community of practice. Global Collegiate Faculty: To ensure instructional alignment, course fidelity, and learner engagement across modalities and geographies. Partnerships/Corporate Learning Solutions: To co-create and customize pathways and programs in response to partner needs and evolving workforce trends. Product Management: To analyze labor market trends, assess program performance relative to market, and guide portfolio decisions. Faculty Affairs and Scheduling Team: To ensure faculty development, teaching quality, and instructional effectiveness across the portfolio . click apply for full job details