Director, Quality Assurance (GMP/GCP)

The Role

The Director of Quality Assurance will be responsible for GMP QA operations for internal manufacturing and external manufacturing at CMOs to support both Agenus and MiNK businesses. This hands-on leadership role includes direct responsibility for GMP batch release and disposition, manufacturing compliance and quality oversight, external vendor compliance including quality agreements & audits, deviation, change control, risk assessment, investigation and CAPA management, oversight of validation activities, and regulatory inspection readiness.

The Director will also provide Quality oversight and support for clinical development activities, partnering with Clinical Operations to address GCP compliance, clinical Quality Events, CRO oversight, and inspection readiness. This individual will work closely with the Quality Systems function to ensure effective implementation and execution of established Quality processes across GMP and GCP activities.

This role is required to be onsite in Lexington, MA.

In The Role You Will

• Support batch record and SOP/method development, review executed batch records and testing records, and disposition onsite and CMO-manufactured drug product to support clinical demand.
• Oversee GMP QA operational activities and develop or enhance manufacturing-related Quality procedures in partnership with Quality Systems.
• Review stability protocols and results, excursions and complaints, ensuring timely investigation and resolution.
• Partner with Quality Systems to ensure effective execution of GMP and GCP Quality processes, including deviations, CAPAs, change controls, risk assessments, and investigations.
• Oversee FDA, EMA, and other global regulatory inspections, ensuring readiness and timely resolution of inspection observations and commitments.
• Partner with Manufacturing, Quality Control, Clinical Operations, Regulatory Affairs, and R&D teams to ensure Quality is integrated throughout product development.
• Direct vendor and CMO Quality oversight, including supplier qualification, audits, Quality Agreements, vendor changes, and performance monitoring. Ensure ongoing compliance with external manufacturing and testing partners.
• Lead and contribute to GMP Quality investigations, deviations, CAPAs, change controls, risk assessments, out-of-specification investigations, and product disposition activities, ensuring appropriate documentation, resolution, and effectiveness.
• Provide Quality oversight and guidance to Clinical Operations on GCP compliance, including clinical Quality Events, protocol deviations, CRO/vendor Quality issues, investigations, and CAPAs.
• Support risk-based GCP Quality oversight activities, including CRO and clinical vendor audits, inspection readiness, and resolution of clinical compliance findings, partnering with specialized GCP resources as appropriate.
• Support validation activities, including equipment/facility qualification, process validation, analytical method validation, technology transfer, and associated Quality oversight.
• Support Quality contributions to IND, BLA, and other global regulatory submissions as needed.
• Lead, mentor, and develop Quality team members, fostering accountability, collaboration, and continuous improvement.
• Stay current with evolving regulatory requirements and industry best practices, translating them into actionable Quality strategies.

Qualifications: About You

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 10+ years of progressive Quality Assurance experience within the biotechnology or pharmaceutical industry, including leadership responsibilities.
• Experience supporting biologics, cell therapy, and/or advanced therapy medicinal products (ATMPs) preferred.
• Strong expertise in GMP regulations and manufacturing Quality operations, with working knowledge of applicable FDA, EMA, JP, ICH, GCP, and GLP requirements.
• Strong working knowledge of GMP manufacturing operations supporting biologics and/or cell therapy products.
• Experience managing Quality oversight of CMOs, contract testing laboratories, and external vendors, including supplier qualification, audits, and Quality Agreements.
• Experience supporting GCP Quality activities in clinical development, including CRO oversight, clinical Quality Events, protocol deviations, investigations, CAPAs, or GCP inspection readiness preferred.
• Demonstrated experience leading or supporting FDA and international regulatory inspections and maintaining inspection readiness.
• Experience supporting equipment/facility qualification, process validation, analytical method validation, and technology transfer activities preferred.
• Experience supporting Quality activities across the product lifecycle, from early development through commercialization.
• Demonstrated experience with CAPA, deviations, investigations, change control, risk management, and continuous improvement initiatives.
• Excellent written, verbal, and interpersonal communication skills with the ability to influence cross-functional teams and senior leadership.
• Demonstrated ability to lead cross-functional teams and build collaborative partnerships across Manufacturing, Quality Control, Clinical Operations, Regulatory Affairs, and R&D.
• Strong organizational skills with the ability to prioritize multiple projects while maintaining attention to detail.
• Ability to work independently, exercise sound judgment, and thrive in a dynamic, evolving biotechnology environment.

The targeted salary range for this position is $170,000 - $218,000 per year. Agenus is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with Agenus’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.

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