Director, GCP Quality Assurance
Acadia Pharmaceuticals
September 03, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Position Summary
The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across the clinical development portfolio to ensure compliance with global regulatory requirements and internal quality standards. Provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness, and serves as a GCP compliance subject matter expert.
Primary Responsibilities
- Plan, schedule, conduct, and manage internal/external GCP audits of CSPs, CROs, investigator sites, and vendors
- Prepare/review/finalize audit reports; document observations, risks, and corrective actions; track to resolution
- Develop/review/maintain GCP Quality Agreements with CROs, CSPs, and clinical study partners
- Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews and continuous improvement
- Develop/review/maintain SOPs and quality documents supporting GCP auditing and compliance
- Manage internal GCP audit program (planning, execution, follow-up, and effectiveness assessments)
- Support mock and regulatory inspections and responses for GCP studies/quality systems
- Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other global requirements
- Recommend and implement improvements to GCP quality systems, processes, and procedures
Education & Experience (Required)
- Bachelor’s in Life Sciences or related field (or equivalent education/experience)
- 10+ years in pharmaceutical/biotech/regulated industry
- 5+ years in GCP Quality Assurance, compliance, and auditing
- Lead Auditor experience for internal/external GCP audits
- Strong knowledge of ICH-GCP and applicable FDA/EU/international GCP regulations
- Audit experience covering CROs, investigator sites, and GCP service providers
- Experience supporting regulatory inspections/inspection readiness
Preferred Qualifications
- SQA/ASQ/Lead Auditor certification
- Experience conducting global audits across US/EU/UK/Japan and other regions
- Experience with eCOA, CSV, and data management
Benefits (as stated)
- Medical, dental, vision; 401(k) match 1:1 up to 5%; equity; bonus; life/disability/EAP; tuition assistance; paid time off; paid parental leave; sick time.
Physical/Other
- Ability to travel overnight independently and work after hours if required.
- Occasionally lift/move up to 15 pounds.
The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across the clinical development portfolio to ensure compliance with global regulatory requirements and internal quality standards. Provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness, and serves as a GCP compliance subject matter expert.
Primary Responsibilities
- Plan, schedule, conduct, and manage internal/external GCP audits of CSPs, CROs, investigator sites, and vendors
- Prepare/review/finalize audit reports; document observations, risks, and corrective actions; track to resolution
- Develop/review/maintain GCP Quality Agreements with CROs, CSPs, and clinical study partners
- Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews and continuous improvement
- Develop/review/maintain SOPs and quality documents supporting GCP auditing and compliance
- Manage internal GCP audit program (planning, execution, follow-up, and effectiveness assessments)
- Support mock and regulatory inspections and responses for GCP studies/quality systems
- Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other global requirements
- Recommend and implement improvements to GCP quality systems, processes, and procedures
Education & Experience (Required)
- Bachelor’s in Life Sciences or related field (or equivalent education/experience)
- 10+ years in pharmaceutical/biotech/regulated industry
- 5+ years in GCP Quality Assurance, compliance, and auditing
- Lead Auditor experience for internal/external GCP audits
- Strong knowledge of ICH-GCP and applicable FDA/EU/international GCP regulations
- Audit experience covering CROs, investigator sites, and GCP service providers
- Experience supporting regulatory inspections/inspection readiness
Preferred Qualifications
- SQA/ASQ/Lead Auditor certification
- Experience conducting global audits across US/EU/UK/Japan and other regions
- Experience with eCOA, CSV, and data management
Benefits (as stated)
- Medical, dental, vision; 401(k) match 1:1 up to 5%; equity; bonus; life/disability/EAP; tuition assistance; paid time off; paid parental leave; sick time.
Physical/Other
- Ability to travel overnight independently and work after hours if required.
- Occasionally lift/move up to 15 pounds.