Director, Quality Assurance

About Agenus

Agenus is a collaborative team of scientists, physicians, and business leaders dedicated to advancing therapies that harness the immune system's power to fight cancer. We foster an environment rich in learning, innovation, and teamwork, committed to fulfilling the promise of immuno-oncology.

Role Overview

The Director of Quality Assurance will lead GMP QA activities across internal and external manufacturing sites, including Clinical Development partnerships to maintain GCP compliance and inspection readiness. This position is based onsite in Lexington, MA.

Key Responsibilities

• Manage and continuously improve the electronic Quality Management System (eQMS) supporting compliant document control for the enterprise QMS.
• Assist in developing master batch records and SOPs, review deviations and batch records, oversee disposition decisions for onsite and CMO drug products, and ensure timely batch releases per regulations.
• Lead the establishment and enhancement of GMP, GCP, and GLP quality systems supporting both clinical and commercial initiatives.
• Oversee readiness and conduct of regulatory inspections by FDA, EMA, and other global authorities, including resolving observations timely.
• Collaborate with Manufacturing, Clinical Operations, Regulatory Affairs, and R&D to embed quality throughout product development stages.
• Provide leadership for vendor and CMO quality oversight involving audits, quality agreements, and performance monitoring; manage supplier qualification and compliance.
• Drive risk management, CAPA programs, deviation investigations, and quality system processes including Change Control, Deviations, Complaints, and Product Disposition.
• Support validation processes such as equipment qualification, process and analytical validations, technology transfers, and quality oversight thereof.
• Contribute to quality aspects in regulatory submissions including INDs and BLAs.
• Lead and mentor a high-performing QA team promoting accountability and professional growth.
• Monitor regulatory changes and industry standards to update company quality strategies accordingly.

Candidate Profile

• Bachelor's degree in a scientific field is required; advanced degrees are preferred.
• Minimum of 10 years' progressive Quality Assurance experience in biotech or pharma, including leadership roles.
• Experience with biologics, cell therapy, or advanced therapy medicinal products (ATMPs) is advantageous.
• Deep knowledge of global GMP, GCP, and GLP regulations including FDA, EMA, and ICH guidelines.
• Familiarity with GMP manufacturing practices supporting biologics or cell therapies.
• Proficient with electronic QMS platforms (e.g., ZenQMS) covering document control, CAPA, training, and quality metrics.
• Experience managing quality oversight of CMOs, contract labs and vendors including audits and quality agreements.
• Proven track record in regulatory inspection preparedness and response globally.
• Knowledge of validation processes such as equipment qualification and technology transfer.
• Hands-on experience with quality lifecycle activities from early development to commercialization.
• Strong capabilities in risk management, CAPA, deviation control, change management, and continuous quality improvement.
• Excellent communication and interpersonal skills with leadership influence across cross-functional teams.
• Effective team leadership fostering collaboration with Manufacturing, Clinical, Regulatory, and R&D functions.
• Outstanding organizational skills to manage multiple priorities with attention to detail.
• Capability to work independently and adapt in a fast-changing biotech environment.

Compensation

The expected salary range is $170,000 to $218,000 annually, aligned with company compensation philosophy considering education, experience, market conditions, and internal equity.

Benefits

• Medical, dental, and vision insurance options (US and UK).
• Flexible spending accounts for healthcare and dependent care (US).
• Flexible vacation policy to support work-life balance.
• Care.com memberships for family support (US).
• Educational assistance programs to encourage ongoing learning (US).
• 401(k) matching contributions.
• Employee stock purchase plan.
• Employee Assistance Program providing mental health and wellbeing support.
• Recognition programs celebrating contributions to the mission.

Our Values

• Patients First: Committed to making a difference for every cancer patient.
• Bold & United: Strong teamwork to achieve ambitious goals.
• Integrity Always: Guided by respect and honesty.
• Own It: Accountability in outcomes and processes.
• Always Learning: Curiosity drives continuous innovation.
• Bring Your Best: Dedication to daily excellence.