Director, Quality Assurance

Agenus Inc.•Lexington, MA

3d•$170,000 - $218,000•Onsite

About The Position

The Director of Quality Assurance will oversee GMP QA operations for both internal manufacturing, external manufacturing at CDMOs in addition to supporting clinical compliance to GCPs and Inspection Readiness in collaboration with Agenus Clinical Development leadership. This role is required to be onsite in Lexington, MA. In the role you will maintain and continually improve the Agenus electronic Quality Management System (eQMS) platform and systems and enable compliant electronic and paper-based document control and archiving for the Agenus Enterprise Quality Management System (QMS). Support the master batch record and SOP development, review deviations and executed batch records, and disposition onsite and CMO manufactured drug product. Review and approve executed batch records, support product disposition decisions, and ensure timely batch release in compliance with regulatory requirements. 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, Clinical Operations, Regulatory Affairs, and R&D to ensure quality is integrated into every stage of product development. Direct vendor and contract manufacturing organization (CMO) quality oversight, including audits, quality agreements, 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, 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.

Requirements

Bachelor's degree in a scientific discipline required
10+ years of progressive Quality Assurance experience within the biotechnology or pharmaceutical industry, including leadership responsibilities.
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 with electronic Quality Management Systems (eQMS) including document control, change control, training, CAPA, deviation management, and quality metrics.
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.
Demonstrated experience with CAPA, deviation 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, build collaborative partnerships across Manufacturing, Clinical Operations, Regulatory Affairs, Technical Operations, and R&D, and drive quality initiatives in a fast-paced environment.
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.

Nice To Haves

advanced degree preferred
Experience supporting biologics, cell therapy, and/or advanced therapy medicinal products (ATMPs) preferred.
Experience with ZenQMS or similar eQMS platforms preferred.
Experience supporting equipment qualification, process validation, analytical method validation, and technology transfer activities preferred.

Responsibilities

Maintain and continually improve the Agenus electronic Quality Management System (eQMS) platform and systems and enable compliant electronic and paper-based document control and archiving for the Agenus Enterprise Quality Management System (QMS).
Support the master batch record and SOP development, review deviations and executed batch records, and disposition onsite and CMO manufactured drug product.
Review and approve executed batch records, support product disposition decisions, and ensure timely batch release in compliance with regulatory requirements.
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, Clinical Operations, Regulatory Affairs, and R&D to ensure quality is integrated into every stage of product development.
Direct vendor and contract manufacturing organization (CMO) quality oversight, including audits, quality agreements, 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, 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.