Director, GMP/GxP Quality Assurance

Agenus Inc.; Lexington (MA); On-site; USD 170,000 - 218,000; Full time

Job summary

Agenus is seeking a Director of Quality Assurance for onsite work in Lexington, MA. The role oversees GMP QA operations for internal and CDMO manufacturing, ensuring compliance for clinical and commercial programs.

The ideal candidate has 10+ years in biotech/pharma QA with leadership, extensive GMP/GCP/GLP knowledge, and experience managing CMOs and regulatory inspections. This position emphasizes cross-functional collaboration and proactive quality oversight.

Qualifications

• Bachelor's degree in science required; advanced degree preferred.
• 10+ years of progressive QA experience in biotech/pharma with leadership responsibilities.
• Strong working knowledge of GMP, FDA, EMA, ICH, and global GMP, GCP, GLP regulations.
• Experience managing CMOs, supplier qualification, audits, and Quality Agreements.
• Experience leading FDA and international regulatory inspections and maintaining inspection readiness.

Responsibilities

• Oversee GMP QA operations for internal and external manufacturing at CDMOs.
• Lead development and improvement of GMP, GCP, GLP quality systems.
• Manage inspections, host regulatory visits, and resolve observations.
• Partner with Manufacturing, QC, Clinical Operations, Regulatory, and R&D to embed quality.
• Oversee vendor audits, QA agreements, and supplier qualification.
• Drive CAPA, change control, risk management, and deviation investigations.
• Support regulatory submissions and validation activities as needed.
• Mentor and develop a high-performing QA team.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Inspection readiness

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Agenus is seeking a Director of Quality Assurance for onsite work in Lexington, MA. The role oversees GMP QA operations for internal and CDMO manufacturing, ensuring compliance for clinical and commercial programs.

The ideal candidate has 10+ years in biotech/pharma QA with leadership, extensive GMP/GCP/GLP knowledge, and experience managing CMOs and regulatory inspections. This position emphasizes cross-functional collaboration and proactive quality oversight.