Director, GCP Quality Assurance
Acadia Pharmaceuticals
September 03, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across Acadia’s 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 subject matter expert on GCP compliance.
Primary Responsibilities:
- Plan, schedule, conduct, and manage internal/external GCP audits of Contract Service Providers (CSPs), CROs, investigator sites, and supporting vendors.
- Prepare, review, and finalize audit reports; document observations, risks, and corrective actions through resolution.
- Develop, review, and maintain GCP Quality Agreements with CROs, CSPs, and other clinical study partners.
- Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews, inspection readiness, and continuous improvement.
- Develop/review/maintain SOPs and quality documents for GCP auditing and compliance.
- Manage the internal GCP audit program (planning, execution, follow-up, effectiveness).
- Support mock and regulatory inspections and related responses.
- Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other applicable global requirements.
- Recommend and implement improvements to GCP quality systems, processes, and procedures.
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences (or related field) or equivalent education/experience.
- 10+ years in the pharmaceutical/biotech/regulated industry.
- 5+ years in GCP Quality Assurance, compliance, and auditing.
- Demonstrated experience as a Lead Auditor for internal/external GCP audits.
- Strong knowledge of ICH-GCP and applicable FDA/EU/international regulations.
- Experience auditing CROs, investigator sites, vendors, and GCP service providers.
- Experience supporting regulatory inspections and inspection readiness.
Preferred Qualifications:
- SQA, ASQ, or Lead Auditor certification.
- Experience conducting global audits across US/EU/UK/Japan and other regions.
- Experience with eCOA, CSV, and data management.
Benefits:
- Discretionary bonus and equity awards (amounts vary by performance/experience/location).
- Salary range: $165,900–$207,400.
- Medical/dental/vision; employer-paid life/disability/business travel/EAP.
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan.
- 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.
The Director, GCP Quality Assurance leads Good Clinical Practice (GCP) audit activities across Acadia’s 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 subject matter expert on GCP compliance.
Primary Responsibilities:
- Plan, schedule, conduct, and manage internal/external GCP audits of Contract Service Providers (CSPs), CROs, investigator sites, and supporting vendors.
- Prepare, review, and finalize audit reports; document observations, risks, and corrective actions through resolution.
- Develop, review, and maintain GCP Quality Agreements with CROs, CSPs, and other clinical study partners.
- Maintain GCP audit metrics and deliver quality/compliance reporting for management reviews, inspection readiness, and continuous improvement.
- Develop/review/maintain SOPs and quality documents for GCP auditing and compliance.
- Manage the internal GCP audit program (planning, execution, follow-up, effectiveness).
- Support mock and regulatory inspections and related responses.
- Provide GCP compliance guidance to cross-functional stakeholders to ensure adherence to FDA, ICH, EU, and other applicable global requirements.
- Recommend and implement improvements to GCP quality systems, processes, and procedures.
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences (or related field) or equivalent education/experience.
- 10+ years in the pharmaceutical/biotech/regulated industry.
- 5+ years in GCP Quality Assurance, compliance, and auditing.
- Demonstrated experience as a Lead Auditor for internal/external GCP audits.
- Strong knowledge of ICH-GCP and applicable FDA/EU/international regulations.
- Experience auditing CROs, investigator sites, vendors, and GCP service providers.
- Experience supporting regulatory inspections and inspection readiness.
Preferred Qualifications:
- SQA, ASQ, or Lead Auditor certification.
- Experience conducting global audits across US/EU/UK/Japan and other regions.
- Experience with eCOA, CSV, and data management.
Benefits:
- Discretionary bonus and equity awards (amounts vary by performance/experience/location).
- Salary range: $165,900–$207,400.
- Medical/dental/vision; employer-paid life/disability/business travel/EAP.
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan.
- 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.