Sr Director, GCP Quality Assurance
Rigel Pharmaceuticals Inc.
7 months ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Enterprise Program Leadership & Strategy
- Define and lead the global GCP quality plan aligned with corporate and clinical objectives
- Establish and maintain an integrated GCP compliance program with Pharmacovigilance (PV) interfaces aligned with FDA, EMA, ICH, and global regulatory requirements
- Build and continuously improve a scalable, risk-based quality management system for a biopharmaceutical company with an active development pipeline
- Integrate GCP with PV, Regulatory, and broader GxP domains to ensure end-to-end compliance
- Serve as a trusted advisor to Clinical Operations, Biometrics, Clinical Science, Supply Chain, Drug Safety, Regulatory, and Technical Operations
- Support digital and scalable solutions to modernize quality operations and reporting
Operational Oversight
- Lead SOP development, harmonization, and governance framework design
- Own and execute the annual GCP/PV audit plan (sites, CROs, vendors, internal processes)
- Oversee audits, CAPAs, root cause analysis, effectiveness checks, and trend reporting
- Ensure robust CRO/vendor oversight
- Provide end-to-end quality oversight for clinical trial development and conduct
Inspection Readiness & Regulatory Leadership
- Lead GCP inspection readiness strategy and execution
- Prepare teams for FDA, EMA, and global inspections; serve as GCP lead during regulatory interactions
- Conduct mock inspections and readiness assessments
Training, Culture & Governance
- Develop role-based GCP training programs and ongoing regulatory education
- Drive change management initiatives to strengthen quality culture
- Establish quality KPIs and metrics; present ongoing risk and compliance insights
- Monitor evolving regulatory expectations and industry best practices
Qualifications & Requirements
- 12–15 years of progressive GCP and/or clinical operations experience in biopharma (development and commercial-stage experience preferred)
- Demonstrated experience building/scaling GCP quality systems and leading audit programs
- Direct experience supporting global regulatory inspections
- Strong expertise in ICH GCP (E6 R2/R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), EMA guidance, and risk-based quality management
- Hands-on, solution-oriented mindset balancing strategy and detailed execution
- Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD, or equivalent) preferred
- Define and lead the global GCP quality plan aligned with corporate and clinical objectives
- Establish and maintain an integrated GCP compliance program with Pharmacovigilance (PV) interfaces aligned with FDA, EMA, ICH, and global regulatory requirements
- Build and continuously improve a scalable, risk-based quality management system for a biopharmaceutical company with an active development pipeline
- Integrate GCP with PV, Regulatory, and broader GxP domains to ensure end-to-end compliance
- Serve as a trusted advisor to Clinical Operations, Biometrics, Clinical Science, Supply Chain, Drug Safety, Regulatory, and Technical Operations
- Support digital and scalable solutions to modernize quality operations and reporting
Operational Oversight
- Lead SOP development, harmonization, and governance framework design
- Own and execute the annual GCP/PV audit plan (sites, CROs, vendors, internal processes)
- Oversee audits, CAPAs, root cause analysis, effectiveness checks, and trend reporting
- Ensure robust CRO/vendor oversight
- Provide end-to-end quality oversight for clinical trial development and conduct
Inspection Readiness & Regulatory Leadership
- Lead GCP inspection readiness strategy and execution
- Prepare teams for FDA, EMA, and global inspections; serve as GCP lead during regulatory interactions
- Conduct mock inspections and readiness assessments
Training, Culture & Governance
- Develop role-based GCP training programs and ongoing regulatory education
- Drive change management initiatives to strengthen quality culture
- Establish quality KPIs and metrics; present ongoing risk and compliance insights
- Monitor evolving regulatory expectations and industry best practices
Qualifications & Requirements
- 12–15 years of progressive GCP and/or clinical operations experience in biopharma (development and commercial-stage experience preferred)
- Demonstrated experience building/scaling GCP quality systems and leading audit programs
- Direct experience supporting global regulatory inspections
- Strong expertise in ICH GCP (E6 R2/R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), EMA guidance, and risk-based quality management
- Hands-on, solution-oriented mindset balancing strategy and detailed execution
- Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD, or equivalent) preferred