Director, GMP Quality Assurance

The Position

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.

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.

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