Senior Director / Head of Quality - South San Francisco, CA (Hybrid)
An innovative, clinical-stage biotechnology company is seeking a Senior Director / Head of Quality to lead and scale its Quality function. This is a high-impact leadership role responsible for defining Quality strategy, building robust GxP systems, and ensuring inspection readiness as programs advance into later-stage clinical development and toward commercialization.
Reporting to executive leadership, this individual will oversee Quality operations, vendor oversight, and compliance across GCP, GMP, and broader GxP activities, while developing a high-performing Quality team.
Key Responsibilities
- Define and lead the company’s global GxP Quality strategy
- Provide Quality leadership across internal teams and external partners (CROs, CMOs, labs, and vendors)
- Build and scale a phase-appropriate Quality framework from early development through commercialization
- Develop, implement, and continuously improve Quality Systems, SOPs, and processes
- Ensure alignment with global regulatory requirements (FDA, EMA, ICH, etc.)
- Oversee document control systems and lifecycle management
- Provide Quality oversight for clinical programs and CRO activities
- Ensure GCP compliance and readiness for clinical inspections
- Lead GMP vendor oversight across manufacturing, testing, packaging, labeling, and distribution
- Partner closely with CMC teams to ensure compliance across the product lifecycle
- Provide Quality input into regulatory submissions and agency interactions (INDs, CTAs, IMPDs)
- Support responses to health authority queries and inspections
- Drive inspection readiness across all GxP areas
- Serve as the primary Quality representative during regulatory inspections
- Implement risk-based Quality approaches across development stages
- Lead investigations, deviations, and CAPA processes
- Ensure timely resolution of Quality issues and audit findings
- Manage and develop a small Quality team
- Foster a culture of accountability, collaboration, and continuous improvement
- Deliver GxP training across the organization
Experience & Background
- Bachelor’s degree in a scientific discipline (advanced degree preferred)
- 12+ years of progressive experience in GxP Quality within biotech or pharmaceutical environments
- Experience building or scaling Quality systems in clinical-stage organizations
- Strong knowledge of global GxP regulations (FDA, EMA, ICH)
- Deep experience across both GCP and GMP Quality
- Proven experience with vendor oversight (CROs, CMOs, laboratories)
- Hands-on experience with inspections, audits, and regulatory interactions
- Strong capabilities in root cause analysis, deviation management, and CAPA execution
- Familiarity with eQMS and eTMF systems
- Demonstrated ability to lead Quality strategy in a cross-functional environment
- Strong communication and stakeholder management skills
- Ability to operate both strategically and hands-on
- Proven experience managing and developing teams
- Highly organized with the ability to manage multiple priorities
Notes:
- Hybrid working model with ~3 days per week onsite in South San Francisco
- Travel required for vendor oversight, audits, and inspections