Maze is looking for a Senior Director, Quality to lead the Quality function and evolve GxP processes, ensuring inspection readiness and compliance with global regulations.
Requirements
- Bachelor's degree in a scientific discipline
- 12+ years of progressive experience in biotech or pharma GxP quality assurance and compliance
- Deep knowledge of global GxP regulations
- Proven experience in building and refining QA related systems
- Strong understanding of GMP Quality
- Skilled in GxP training and implementation
- Track record of leading and supporting regulatory inspections
- Experience drafting audit responses and implementing CAPAs
- Proficiency in root cause analysis and CAPA management
- Familiarity with eQMS and eTMF systems
- Experience managing and developing direct reports
Benefits
- Competitive medical, dental, and vision insurance
- Mental health offerings
- Equity incentive plan
- 401(k) program with employer match
- Generous holiday and PTO policy