Director, GCP QA & Global Audits Leader

Acadia Pharmaceuticals; San Diego (CA); On-site; USD 166,000 - 207,000; Full time

Benefits offered by this job

Salary plus discretionary bonus and/or

Equity awards

Job summary

Acadia Pharmaceuticals is seeking a Director of GCP Quality Assurance to provide strategic oversight of GCP quality systems across our clinical development portfolio. You will plan, schedule, and conduct internal and external GCP audits of CSPs, CROs, investigator sites, and vendors to ensure global regulatory compliance.

The role requires extensive Lead Auditor experience, deep knowledge of ICH-GCP, FDA and EU regulations, and the ability to develop SOPs, oversee audit metrics, support

Qualifications

• Bachelor's degree in Life Sciences or related field and relevant experience.
• 10+ years in pharmaceutical/biotech or related regulated industry.
• 5+ years direct experience in GCP QA, compliance, and auditing.
• Lead Auditor experience for internal and external GCP audits.
• Strong knowledge of ICH-GCP and FDA/EU regulations.
• Experience auditing CROs, investigator sites, vendors, and other GCP service providers.
• Experience supporting regulatory inspections and inspection readiness.
• Ability to interpret global GCP regulations into quality systems.

Responsibilities

• Plan, schedule, conduct and manage internal and external GCP audits of CSPs, CROs, investigator sites, and supporting vendors.
• Prepare, review, and finalize audit reports with observations, risks, and corrective actions.
• Lead the development, review, and maintenance of GCP Quality Agreements with CROs, CSPs, and partners.
• Maintain GCP audit metrics and deliver quality and compliance reporting to support management reviews and inspections.
• Develop, review, and maintain SOPs and quality documents supporting GCP auditing and compliance activities.
• Manage the internal GCP audit program, including audit planning, execution, follow-up activities, and effectiveness assessments.
• Support mock inspections, regulatory inspections, and responses related to GCP studies and quality systems.
• Provide GCP compliance guidance and oversight to cross-functional stakeholders while ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements.
• Recommend and implement improvements to GCP quality systems, processes, and procedures to strengthen compliance and operational effectiveness.
• Other duties as assigned.

Skills

Lead Auditor

GCP Knowledge

Regulatory Compliance

Auditing

Cross-functional Collaboration

Education

Bachelor's degree in Life Sciences or related field

10+ years in pharmaceutical/biotech

5+ years in GCP QA/auditing

Lead Auditor certification (preferred)

Job description

Acadia Pharmaceuticals is seeking a Director of GCP Quality Assurance to provide strategic oversight of GCP quality systems across our clinical development portfolio. You will plan, schedule, and conduct internal and external GCP audits of CSPs, CROs, investigator sites, and vendors to ensure global regulatory compliance.

The role requires extensive Lead Auditor experience, deep knowledge of ICH-GCP, FDA and EU regulations, and the ability to develop SOPs, oversee audit metrics, support