Title: Director, Quality (GMP)
Location: Cambridge, MA (Hybrid)
Position Summary
The Director of Quality & Compliance (GMP) plays a vital leadership role within the Quality & Compliance function, providing operational, regulatory, and system-level expertise for GMP-related activities. This individual will ensure that all GMP efforts-whether executed internally or through external partners-are carried out with a strong focus on patient safety, data integrity, and regulatory compliance.
Key Responsibilities
- Lead and support GMP quality initiatives across internal teams and external collaborators (e.g., CDMOs, testing labs, etc.).
- Ensure consistent execution and governance of GMP compliance programs.
- Participate in cross-functional meetings related to CMC, clinical studies, and development programs to provide quality oversight.
- Maintain and organize GMP-related documentation, systems, and program records.
- Manage the GMP audit program, including conducting qualification audits and supporting investigations as needed.
- Oversee quality program execution, including review, approval, and disposition of key documentation.
- Review and collaborate on the development of SOPs to ensure regulatory compliance.
- Provide support during regulatory inspections and health authority engagements.
- Monitor and report on quality metrics, trends, and audit outcomes to leadership.
Qualifications
Education:
- Bachelor's degree required; advanced degree (MS or PhD) preferred.
Experience:
- Minimum of 15 years in the biotech, pharmaceutical, or medical device industry.
- Strong background in GMP Quality and Compliance; experience with GCP, GLP, or pharmacovigilance is a plus.