Director, Quality Assurance

The Role

The Director of Quality Assurance will oversee GMP QA operations for internal manufacturing and external manufacturing at CDMOs to support both Agenus and MiNK businesses. The operational role includes oversight of quality management systems & compliance, procedures, lot disposition, quality agreements, vendor management, complaints/excursions, audits, validation projects and contribute to regulatory submissions. This role will also support clinical compliance to GCPs and Inspection Readiness in collaboration with Agenus Clinical Development leadership.

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

• Support batch record and SOP/Method development, review quality systems and associated executed batch records and testing records, and disposition onsite and CMO manufactured drug product to support clinical demand.
• Establish, maintain and develop quality procedures to support in-house operations.
• Review stability protocols and results, excursions, complaints and ensure timely response.
• Lead the development, implementation, and continuous improvement of our GMP, GCP, and GLP quality systems to support clinical and commercial programs.
• Oversee FDA, EMA, and other global regulatory inspections, ensuring readiness and successful outcomes. Lead inspection readiness activities, host regulatory inspections, and ensure 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 into every stage of product development.
• Direct vendor and contract manufacturing organization (CMO) quality oversight, including audits, quality agreements, vendor change and performance monitoring. Oversee supplier qualification activities, negotiate and maintain Quality Agreements, and ensure ongoing compliance with external manufacturing and testing partners.
• Drive risk management initiatives, CAPA programs, and deviation investigations to ensure timely resolution and prevention of recurrence. Oversee execution of Quality Systems including Change Control, Deviations, CAPA, Risk Assessments, Complaint Investigations, Out of Specification Investigations and Product Disposition activities.
• Support validation activities including equipment 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 inspire a high-performing team, fostering professional growth and a culture of accountability.
• Stay ahead of evolving regulatory requirements and industry best practices, translating them into actionable strategies for the company.

• 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 working knowledge of GMP regulations with demonstrated knowledge of FDA, EMA, ICH, and applicable global GMP, GCP, and GLP regulations.
• Strong working knowledge of GMP manufacturing operations supporting biologics and/or cell therapy products.
• Experience managing quality oversight of Contract Manufacturing Organizations (CMOs), contract testing laboratories, and external vendors, including supplier qualification, audits, and Quality Agreements.
• Demonstrated experience leading or supporting FDA and international regulatory inspections and maintaining inspection readiness.
• Experience supporting equipment qualification,…