Senior Director, GMP Quality
Generate Biomedicines · Somerville, MA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Senior Director of GMP Quality will establish and maintain quality systems, provide oversight of manufacturing partners and testing laboratories, and ensure regulatory compliance. This hands-on leadership role partners with cross-functional teams from development through commercialization and reports to the Vice President of Quality.
What they're looking for
- Extensive GMP quality systems and CMC strategy experience
- Knowledge of analytical testing, manufacturing, validation, and lifecycle management
- Experience managing relationships with CDMOs and contract laboratories
- Understanding of regulatory requirements and GxP compliance
- Leadership experience building quality culture and risk management practices
- Ability to advise senior leadership on product quality and supply continuity
What you'll be doing
- Establish scalable, risk-based quality framework for analytical, manufacturing, and validation activities
- Provide independent quality oversight of CMC strategies, control strategies, and specifications
- Lead quality relationships with external partners including audits and performance management
- Advise Technical Operations, Regulatory Affairs, and executive teams on quality and regulatory readiness
- Foster quality culture focused on scientific rigor and proactive risk management
Privacy & handoff
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