Backed by a16z and GV.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
More about this role
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.
- Provide GMP Quality oversight for development programs from early development...
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