Director, GMP Quality Assurance

The Position

At Maze, we're translating human genetic insights into precision medicines for patients with serious diseases. With our lead program, MZE829, preparing to advance into pivotal development and MZE782 in Phase 2, we are entering an important stage in building the capabilities needed to support late-stage development and eventual commercialization.

As Director, GMP Quality, you'll play a key role in advancing Maze's small molecule programs from clinical development toward commercialization. You'll lead GMP Quality oversight across our development programs and external manufacturing network, partnering closely with Technical Operations, Supply Chain, Regulatory Affairs, and other cross-functional stakeholders to ensure sound Quality decisions, phase-appropriate execution, and inspection readiness. You'll also help build and scale the Quality systems and capabilities needed as our programs and organization mature.

Reporting to the Head of Quality, you'll lead and develop a small GMP Quality team and provide cross-functional Quality leadership, while remaining directly involved in critical GMP activities.

The Impact You’ll Have

• 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.

As a Director, we also expect our leaders to demonstrate the following Leadership Competencies:

• Communication and Influence

• Builds communication channels across Maze for sharing information

• Influences Senior Management decisions through persuasive arguments

• Respectfully addresses differing opinions leading to support of decision

• Teamwork and Collaboration

• Champions partnerships and connections across Maze

• Proactively addresses issues that could result in breakdown of team relationships

• Spotlights team and individual contributions in public forums

• Execution and Results

• Addresses gaps and leverages strengths to get best results

• Maintains a steadying presence and clarifies priorities during change

• Anticipates and removes barriers that put functional/corporate goals at risk

• Develop Others and Self

• Removes barriers to staff development and empowers them to make their own decisions

• Stays current on industry trends and keeps direct-reports prepared and responsive

What We’re Looking For

• 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

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week .   Willingness to travel domestically and internationally for inspections, vendor oversight, and industry events.

##

About Maze Therapeutics

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.

Our People

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 – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $219,000 - $267,000 . Additionally, this position is eligible for an annual performance bonus.

Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

#LI-Hybrid