Director, GMP Quality Assurance

Maze Therapeutics•South San Francisco, CA

11d•$219,000 - $267,000•Hybrid

About The Position

At Maze Therapeutics, the Director, GMP Quality Assurance will help advance small molecule programs from clinical development toward commercialization. The role leads GMP Quality oversight across development programs and an external manufacturing network, partnering with Technical Operations, Supply Chain, Regulatory Affairs, and other stakeholders to support sound Quality decisions, phase-appropriate execution, and inspection readiness. The position also helps build and scale Quality systems and capabilities as the programs and organization mature. Reporting to the Head of Quality, this role leads and develops a small GMP Quality team and provides cross-functional Quality leadership while remaining directly involved in critical GMP activities. The position follows a hybrid schedule, with at least three days per week onsite at Maze’s South San Francisco headquarters, and requires domestic and international travel for inspections, vendor oversight, and industry events.

Requirements

Bachelor’s degree in a scientific discipline such as chemistry, pharmaceutical sciences, or a related field.
10+ years of progressive biotech or pharmaceutical GMP Quality Assurance experience, including direct experience in small molecule drug development.
Demonstrated experience supporting a small molecule drug product through late-stage development and commercial readiness, including process validation, PPQ, and technology transfer to commercial manufacturing.
Demonstrated experience supporting GMP Quality across drug substance, drug product, formulation, packaging, labeling, and distribution, including testing, stability, and retention.
Deep knowledge of global GMP regulations and guidance, including 21 CFR Parts 210 and 211, EU GMP/EudraLex Volume 4, relevant ICH guidelines, and other applicable standards.
Familiarity with 21 CFR Part 11 and EU Annex 11 computer systems validation requirements.
Experience with disposition and release of investigational materials in compliance with applicable GMP requirements.
Track record supporting FDA regulatory inspections.
Demonstrated experience with GMP audits, investigations, root cause analysis, and CAPA development and implementation.
Experience managing and developing direct reports, with a focus on mentorship and professional growth.
Willingness to travel domestically and internationally for inspections and vendor oversight.

Nice To Haves

Technical experience in drug substance or drug product manufacturing and/or testing.
Experience with EU/EEA competent authorities and other global regulatory authorities.

Responsibilities

Provide GMP Quality oversight for development programs from early development through commercial launch, including phase-appropriate systems and inspection readiness.
Represent GMP Quality on internal cross-functional teams and program initiatives, advising on development and manufacturing decisions.
Oversee GMP manufacturing and testing at external CDMOs/CMOs in partnership with Technical Operations.
Ensure timely batch record review, product disposition, and release of investigational materials.
Lead GMP QA investigations and ensure timely, effective resolution of deviations, complaints, audit and inspection findings, and associated CAPAs across internal and outsourced GMP activities.
Develop and continuously improve phase-appropriate GMP Quality Systems, processes, and SOPs aligned with ICH Q9 and ICH Q10 principles.
Support commercial readiness, including process performance qualification (PPQ), technology transfer, and preparation for commercial manufacturing and launch.
Manage and develop direct reports, while mentoring and supporting professional growth across the Quality team.
Build communication channels across Maze for sharing information.
Influence Senior Management decisions through persuasive arguments and respectfully address differing opinions to build support for decisions.
Champion partnerships and connections across Maze, proactively address issues that could damage team relationships, and recognize team and individual contributions.
Address gaps and leverage strengths to achieve results, maintain a steadying presence and clarify priorities during change, and anticipate and remove barriers to functional and corporate goals.
Remove barriers to staff development, empower staff to make decisions, stay current on industry trends, and keep direct reports prepared and responsive.
Travel domestically and internationally for inspections, vendor oversight, and industry events.