Director, Clinical QA
Neurocrine Biosciences
August 26, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role
- Develop strategy and operating plans for Clinical QA; establish compliance, procedures, and quality leadership.
- Build and lead Clinical QA team to implement quality systems and support clinical study teams.
- Lead through pre-approval inspections and clinical audits.
- Coordinate with regulatory, clinical, drug safety, and medical affairs to ensure quality standards and risk-based principles.
- Ensure budget, schedules, and department performance requirements are met.
Your Contributions (include, but are not limited to)
- Develop and execute Clinical QA strategy; drive GCP compliance and quality objectives.
- Lead GCP QA vision, goals, capabilities, and quality culture.
- Provide quality guidance and interpretation of GCP requirements with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs.
- Prepare for and participate in regulatory inspections (readiness planning, mock inspections, pre-approval inspections).
- Develop and enhance the clinical QMS.
- Evaluate/oversee compliance audit strategy and oversight of investigators, clinical labs, and CROs.
- Monitor principal investigator regulatory status; support remediation/corrective action.
- Support INDs and ex-US CTAs and correspondence.
- Develop and communicate compliance metrics/trending.
- Conduct investigator site and vendor audits for Phase I–IV data integrity and GCP/regulatory compliance.
- Oversee compliance for drug safety/pharmacovigilance, Phase IV, and investigator-initiated trials.
- Oversee internal audits for GCP compliance.
Requirements
- RN/BSN/BS/MS/BA (or equivalent) + 12+ years industry experience including GCP leadership; extensive GCP audits/inspections; experience developing/implementing GCP QA systems/procedures; managerial experience.
OR
- Master’s in similar field + 10+ years equivalent experience.
- Strong GCP expertise; knowledge of FDA/ICH and international GCP (including FDA & EMA focus), plus GxP (GLP and/or GMP).
- Proven leadership, communication, relationship-building, and ability to manage complex/multiple workstreams.
- Ability to design audit programs and conduct audits; solve complex issues and troubleshoot.
Benefits (as stated)
- Base salary: $181,800–$248,000; annual bonus target 35%; equity long-term incentive eligibility.
- Retirement savings match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
- Develop strategy and operating plans for Clinical QA; establish compliance, procedures, and quality leadership.
- Build and lead Clinical QA team to implement quality systems and support clinical study teams.
- Lead through pre-approval inspections and clinical audits.
- Coordinate with regulatory, clinical, drug safety, and medical affairs to ensure quality standards and risk-based principles.
- Ensure budget, schedules, and department performance requirements are met.
Your Contributions (include, but are not limited to)
- Develop and execute Clinical QA strategy; drive GCP compliance and quality objectives.
- Lead GCP QA vision, goals, capabilities, and quality culture.
- Provide quality guidance and interpretation of GCP requirements with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs.
- Prepare for and participate in regulatory inspections (readiness planning, mock inspections, pre-approval inspections).
- Develop and enhance the clinical QMS.
- Evaluate/oversee compliance audit strategy and oversight of investigators, clinical labs, and CROs.
- Monitor principal investigator regulatory status; support remediation/corrective action.
- Support INDs and ex-US CTAs and correspondence.
- Develop and communicate compliance metrics/trending.
- Conduct investigator site and vendor audits for Phase I–IV data integrity and GCP/regulatory compliance.
- Oversee compliance for drug safety/pharmacovigilance, Phase IV, and investigator-initiated trials.
- Oversee internal audits for GCP compliance.
Requirements
- RN/BSN/BS/MS/BA (or equivalent) + 12+ years industry experience including GCP leadership; extensive GCP audits/inspections; experience developing/implementing GCP QA systems/procedures; managerial experience.
OR
- Master’s in similar field + 10+ years equivalent experience.
- Strong GCP expertise; knowledge of FDA/ICH and international GCP (including FDA & EMA focus), plus GxP (GLP and/or GMP).
- Proven leadership, communication, relationship-building, and ability to manage complex/multiple workstreams.
- Ability to design audit programs and conduct audits; solve complex issues and troubleshoot.
Benefits (as stated)
- Base salary: $181,800–$248,000; annual bonus target 35%; equity long-term incentive eligibility.
- Retirement savings match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.