Senior Director, Quality

Role: Head of Quality (Senior Director)

Responsibilities:
- Own and evolve Maze’s GxP Quality strategy across internal operations and external partners (CROs, CMOs, CTLs, and other GxP vendors)
- Drive cross-functional Quality integration across programs to ensure timely involvement in key decisions
- Develop and implement risk-based Quality approaches for investigational materials; ensure phase-appropriate systems from early development through commercialization; identify and mitigate quality risks
- Lead development and continuous improvement of Quality Systems and GxP SOPs
- Provide Quality oversight/input for regulatory submissions and correspondence (INDs, IMPDs, CTAs) and interactions with FDA and global health authorities
- Provide Quality leadership for clinical programs, including CRO/clinical trial oversight to ensure GCP compliance and inspection readiness
- Partner with CMC and lead GMP vendor oversight to ensure manufacturing, testing, packaging, labeling, and distribution comply with cGMP, FDA, ICH, EMA, and industry standards
- Lead QA investigations (including product-impacting issues) and oversee/approve CAPAs from deviations, complaints, recalls, audits, and inspections; ensure timely resolution and closure
- Lead inspection readiness and serve as the lead Quality representative during health authority inspections
- Represent QA on cross-functional teams and company initiatives, providing Quality guidance for decision-making
- Stay current on evolving global GxP regulations and best practices; apply insights to strengthen Quality frameworks
- Develop and deliver GxP training across Maze and embed best practices into day-to-day operations
- Oversee Document Control for compliance, consistency, and lifecycle management of Quality records

Qualifications / 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, including U.S. CFR, EMA, and ICH
- Proven experience building/refining QA systems supporting clinical and commercial development
- Strong GMP Quality knowledge across raw materials, drug substance, drug product, labeling, packaging, distribution (including testing, stability, retention)
- Strong GCP Quality knowledge, including CRO oversight and clinical inspection readiness
- Experience enabling release of investigational and commercial materials in regulatory compliance
- Skilled in GxP training and implementation (practical adoption)
- Track record leading/supporting regulatory inspections (FDA, EMA, and global agencies)
- 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 with mentorship/growth focus
- Collaborative mindset across internal teams and external partners
- Strong strategic/organizational skills and ability to prioritize multiple projects
- Excellent leadership and communication skills (written and oral)
- High ethical standards; proactive, solution-oriented approach
- Willingness to travel domestically and internationally for inspections, vendor oversight, and industry events

Hybrid/Onsite Requirement:
- Hybrid role; expected to be onsite at South San Francisco headquarters at least three days per week

Benefits (if applicable):
- Eligible employees receive competitive medical, dental, and vision insurance; mental health offerings; equity incentive plan; 401(k) with employer match; generous holiday and PTO policy.
- Annual performance bonus eligibility.

Salary Range (if applicable):
- $257,000 - $314,000 (San Francisco Bay Area)