Generate Biomedicines
Senior Director, GMP Quality
$210K–$290K
Somerville, MA +1 · Director · Full-time · Posted Sep 18, 2026
- Location
- Somerville, MA
Somerville, Massachusetts, United States - Experience
- 15+ years of biopharmaceutical industry experience.
- Education
- Bachelor’s degree in a relevant scientific discipline.
About the job
Leads GMP Quality strategy and oversight for outsourced and internal development, manufacturing, testing, and product lifecycle activities, supporting regulatory compliance from development through commercialization.
What you'll do
- Establish and maintain scalable, risk-based GxP quality systems and provide independent oversight of CMC, analytical, and manufacturing activities.
- Lead quality relationships with CDMOs, testing laboratories, and other partners, including qualification, audits, quality agreements, performance management, and issue escalation.
- Oversee significant quality events, regulatory readiness, submissions, inspections, and product quality risk management.
What they ask for
- Bachelor’s degree in a relevant scientific discipline.
- Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP operations.
- Strong knowledge of quality systems, biologic product regulations, validation, stability, comparability, specifications, and control strategies.
- Experience overseeing external partners, leading audits and remediation, and supporting regulatory submissions, health authority interactions, and inspections.
Nice to have
- Involvement in pre-approval or regulatory inspections and commercialization readiness for biologics.
- Exposure to highly outsourced biotechnology models, quality technologies, or combination drug product development.
Pay
$210,000 — $290,000 USD per year, base salary
Tools
GMP, GLP, GxP, CAPAs, OOS/OOT
Model-written summary · the original posting is authoritative