Senior Director Quality Assurance

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 ResponsibilitiesDefine and lead the company's global GxP Quality strategyProvide 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 commercializationDevelop, implement, and continuously improve Quality Systems, SOPs, and processesEnsure alignment with global regulatory requirements (FDA, EMA, ICH, etc.)Oversee document control systems and lifecycle managementProvide Quality oversight for clinical programs and CRO activitiesEnsure GCP compliance and readiness for clinical inspectionsLead GMP vendor oversight across manufacturing, testing, packaging, labeling, and distributionPartner closely with CMC teams to ensure compliance across the product lifecycleProvide Quality input into regulatory submissions and agency interactions (INDs, CTAs, IMPDs)Support responses to health authority queries and inspectionsDrive inspection readiness across all GxP areasServe as the primary Quality representative during regulatory inspectionsImplement risk-based Quality approaches across development stagesLead investigations, deviations, and CAPA processesEnsure timely resolution of Quality issues and audit findingsManage and develop a small Quality teamFoster a culture of accountability, collaboration, and continuous improvementDeliver GxP training across the organizationExperience & BackgroundBachelor's degree in a scientific discipline (advanced degree preferred)12+ years of progressive experience in GxP Quality within biotech or pharmaceutical environmentsExperience building or scaling Quality systems in clinical-stage organizationsStrong knowledge of global GxP regulations (FDA, EMA, ICH)Deep experience across both GCP and GMP QualityProven experience with vendor oversight (CROs, CMOs, laboratories)Hands-on experience with inspections, audits, and regulatory interactionsStrong capabilities in root cause analysis, deviation management, and CAPA executionFamiliarity with eQMS and eTMF systemsDemonstrated ability to lead Quality strategy in a cross-functional environmentStrong communication and stakeholder management skillsAbility to operate both strategically and hands-onProven experience managing and developing teamsHighly organized with the ability to manage multiple prioritiesNotes:• Hybrid working model with ~3 days per week onsite in South San Francisco• Travel required for vendor oversight, audits, and inspections

Created: 2026-05-08