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About the Role
As Director, GMP Quality at Maze, you will play a key role in advancing small molecule programs from clinical development toward commercialization. You will lead GMP Quality oversight across development programs and external manufacturing, ensuring sound Quality decisions, phase-appropriate execution, and inspection readiness. You will also help build and scale Quality systems and capabilities as the organization matures. Reporting to the Head of Quality, you will lead and develop a small GMP Quality team and provide cross-functional Quality leadership, while remaining directly involved in critical GMP activities.
Responsibilities
- Provide GMP Quality oversight for development programs from early development through commercial launch, ensuring phase-appropriate systems and inspection readiness.
- Represent GMP Quality on internal cross-functional teams and program initiatives, advising on development and manufacturing decisions.
- Provide GMP Quality oversight of 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 and effective resolution of deviations, complaints, audit and inspection findings, and associated CAPAs across Maze's 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.
Requirements
- Bachelor's degree in a scientific discipline (chemistry, pharmaceutical sciences, or related field) and 10+ years' progressive experience in biotech or pharma GMP quality assurance, with direct experience in small molecule drug development.
- Technical experience in drug substance or drug product manufacturing and/or testing preferred.
- Demonstrated experience supporting a small molecule drug product through late-stage development and commercial readiness activities, 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 of supporting FDA regulatory inspections; experience with EU/EEA competent authorities and other global regulatory authorities is desirable.
- 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.
Skills
- Communication and Influence
- Teamwork and Collaboration
- Execution and Results
- Develop Others and Self
Location
- South San Francisco
Work Type
- Hybrid
Experience Level
- 10+ years' progressive experience
Education Level
- Bachelor's degree in a scientific discipline (chemistry, pharmaceutical sciences, or related field)
Salary/Compensations
- $219,000 - $267,000
- Eligible for an annual performance bonus
Benefits
- Competitive medical, dental, and vision insurance
- Mental health offerings
- Equity incentive plan
- 401(k) program with employer match
- Generous holiday and PTO policy
About the Company
- Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases.
- Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1‑mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease.
- We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.
- Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases.
- We are fostering a culture that encourages vision, initiative and the development of talent.
- Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work.
- While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
- Our Core Values: Further Together, Impact Obsessed, Stand True.