Director, Clinical QA

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.

• 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.

• 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 work streams.
• Ability to design audit programs and conduct audits; solve complex issues and troubleshoot.

• 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.