Job Details

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