# Director, GMP Quality Assurance at Maze Therapeutics

> United States · Director+ · QA / Test · open. Source: https://alderhq.app/jobs/greenhouse%3Amazetherapeutics%3A8922611002 (read 2026-11-11).

## Facts (observed)

- Company: [Maze Therapeutics](https://alderhq.app/companies/maze-therapeutics)
- Location text: South San Francisco, CA; Maze
- Where it can be done from (inferred): United States (evidence: "Location: South San Francisco, CA; Maze")
- Posted: 2026-10-29 (13 days ago)
- First seen by alder: 2026-11-07 · last verified: 2026-11-07
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: http://www.mazetx.com/careers/?gh_jid=8922611002

## Pay and sponsorship

- Posted pay: not posted
- Market band for similar posted roles (SF Bay Area, n 10): p25 $215k, median $238k, p75 $279k

## Description (the employer's text)

### 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.

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Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/greenhouse%3Amazetherapeutics%3A8922611002 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.