Director, QA & Compliance - GMP/GLP, Onsite Lexington

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

Benefits offered by this job

Medical, Dental & Vision Coverage – US

Flexible Spending Accounts – US

Flexible Vacation Plan

Education Assistance Program – US

401(k) Match

Employee Stock Purchase Plan

Employee Assistance Program (EAP)

Recognition Program

Job summary

Agenus, a leader in immuno-oncology, is seeking a Director of Quality Assurance to oversee GMP QA operations for internal and external manufacturing and to support regulatory compliance for clinical programs.

The role requires onsite work in Lexington, MA and involves leading QA systems, inspection readiness, and cross-functional collaboration to ensure high-quality biologics products from development through commercialization.

Qualifications

• Bachelor's degree in scientific discipline required; advanced degree preferred.
• 10+ years of progressive QA experience with leadership responsibilities.
• Biologics/cell therapy/ATMPs experience preferred.
• Strong GMP regulatory knowledge (FDA/EMA/ICH) and global GMP/GCP/GLP familiarity.
• Experience with eQMS including document control, change control, CAPA, deviations, training, and metrics.
• Experience overseeing CMOs, supplier qualification, audits, and Quality Agreements.
• Experience leading FDA/international regulatory inspections and inspection readiness.
• Experience with equipment qualification, process validation, analytical method validation, and tech transfer.
• Experience across product lifecycle QA activities from development to commercialization.
• Strong communication and cross-functional leadership abilities.

Responsibilities

• Maintain and improve the eQMS platform and document control/archive for QA.
• Support master batch record, SOP development, deviations, batch records, and disposition.
• Lead GMP, GCP, and GLP quality system development for clinical and commercial programs.
• Oversee inspections by FDA, EMA, and other regulators; ensure readiness and timely responses.
• Partner with Manufacturing, Clinical Ops, Regulatory Affairs, and R&D to embed quality.
• Direct QA oversight of CMOs and external vendors including supplier qualification and Quality Agreements.
• Drive CAPA, deviations, risk management, change control, and quality metrics.
• Support validation activities (equipment/Process/analytical methods) and tech transfer.
• Contribute to IND, BLA submissions as needed.
• Lead, mentor, and develop a high-performing QA team; foster accountability.
• Monitor evolving regulatory requirements and translate into strategy.

Skills

GMP compliance

Regulatory inspections

Quality management

Leadership

Cross-functional collaboration

eQMS / document control

CAPA & deviation management

Risk management

Vendor/CMO oversight

Validation & tech transfer

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

ZenQMS

eQMS platforms

Job description

Agenus, a leader in immuno-oncology, is seeking a Director of Quality Assurance to oversee GMP QA operations for internal and external manufacturing and to support regulatory compliance for clinical programs.

The role requires onsite work in Lexington, MA and involves leading QA systems, inspection readiness, and cross-functional collaboration to ensure high-quality biologics products from development through commercialization.