Senior Director, GMP Quality & Compliance Leader

Generate:Biomedicines; Somerville (MA); On-site; USD 260,000 - 360,000; Full time

Benefits offered by this job

Equity compensation

Job summary

Generate:Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems and provide independent oversight of CDMOs and contract labs. You will work with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain to support programs from development through commercialization.

The ideal candidate offers 15+ years in biopharma, deep GMP/GLP expertise, and a proven track record in quality strategy, audits, and regulatory readiness.

Qualifications

• Extensive GxP quality leadership experience supporting biopharma development and manufacturing.
• Strong understanding of deviations, investigations, CAPAs, change controls, and data integrity.
• Experience supporting regulatory submissions, health authority interactions, inspections, and responses to findings.
• Proven ability to establish phase-appropriate quality strategies and scalable systems.
• Experience leading audits, partner performance management, and risk mitigation.

Responsibilities

• Establish and maintain a scalable, risk-based GxP Quality framework across analytical testing, manufacturing, validation, and lifecycle management.
• Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies.
• Build a culture of quality and accountability across Generate and external partners.
• Lead CDMO and contract testing laboratory relationships, governance, and issue escalation.
• Oversee outsourced development, manufacturing, testing, packaging, and storage activities for clinical supply and GMP release.
• Guide technology transfer, scale-up, process characterization, and continued process verification.

Skills

GxP Quality Leadership

CDMO Oversight

Regulatory Readiness

Quality System Development

Cross-Functional Leadership

Education

Bachelor's degree in a relevant scientific discipline

15+ years biopharmaceutical industry experience

Job description

Generate:Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems and provide independent oversight of CDMOs and contract labs. You will work with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain to support programs from development through commercialization.

The ideal candidate offers 15+ years in biopharma, deep GMP/GLP expertise, and a proven track record in quality strategy, audits, and regulatory readiness.