Senior Director, GMP Quality

The role

The Senior Director, GMP Quality will build and maintain quality systems and provide independent quality oversight of CDMOs, contract testing laboratories, and strategic partners. This hands-on individual contributor leadership role supports programs from development through commercialization by partnering with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain.

What you will do

• Establish and maintain a scalable, risk-based GxP Quality framework
• Provide phase-appropriate Quality oversight of CMC and analytical strategies
• Serve as an enterprise Quality leader and strategic advisor to cross-functional teams
• Lead CMC Quality relationships with CDMOs, contract testing laboratories, and technical partners
• Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage
• Provide Quality leadership across technology transfer, scale-up, and process lifecycle activities
• Review and approve key GMP and regulatory documentation
• Drive product quality risk management, audit readiness, and data integrity
• Support global regulatory submissions and health authority interactions
• Establish and monitor Quality performance indicators

Required qualifications

• Bachelors degree in a relevant scientific discipline
• 15+ years of biopharmaceutical industry experience
• Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP operations
• Strong understanding of quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, data integrity, and inspection readiness
• Experience providing quality oversight across preclinical, CMC, clinical manufacturing, quality control, supply chain, and product lifecycle activities
• Strong knowledge of biologic products regulations, process validation, method validation, stability, comparability, specifications, and control strategies
• Proven ability to establish phase-appropriate Quality strategies and scalable systems for early- and late-stage development programs
• Significant quality oversight experience working with CDMOs, CROs, contract testing laboratories, suppliers, and other external partners
• Experience leading audits, quality agreements, partner performance management, investigations, remediation, and risk mitigation
• Demonstrated success supporting regulatory submissions, health authority interactions, inspections, and responses to regulatory findings
• Experience partnering with Technical Operations, Preclinical, Regulatory, Clinical, Manufacturing, and Supply Chain teams
• Proven ability to build, mentor, develop and lead high performing Quality Teams

Nice to have

• Involvement in pre-approval inspections, regulatory inspections, and commercialization readiness for biologics
• Exposure to highly outsourced or virtual biotechnology operating model
• Involved in implementing new quality technologies, electronic systems, automation, or data-driven quality tools
• Global experience with health authorities, suppliers, and development or manufacturing partners
• Strategic Quality and GMP leadership for combination drug product development

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

Before you apply

• Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates
• Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines

About the company

Generate Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. The company integrates machine learning with large-scale experimentation to design proteins with defined biological intent.