Director, GCP QA & Audit Strategy

ACADIA Pharmaceuticals Inc.; San Francisco (CA); On-site; USD 166,000 - 207,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, vision insurance

Equity awards

401(k) with match

PTO 15+ days

Job summary

Acadia Pharmaceuticals Inc. is seeking a Director, GCP Quality Assurance to lead audit activities across its clinical development portfolio and ensure compliance with global regulatory standards.

The role provides strategic oversight of GCP quality systems, manages audit programs, and supports inspection readiness. The candidate should have 10+ years in pharma, 5+ years in GCP QA, Lead Auditor experience, and strong ICH-GCP knowledge; experience with regulatory inspections is a plus.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years in pharma/biotech or related regulated industry.
• 5+ years in GCP Quality Assurance, compliance and auditing.
• Experience as Lead Auditor for internal/external GCP audits.
• Strong knowledge of ICH-GCP, FDA, EU regulations.
• Experience auditing CROs, investigator sites, vendors, and GCP service providers.
• Experience supporting regulatory inspections and inspection readiness.

Responsibilities

• Plan, schedule, conduct, and manage internal and external GCP audits of CSPs, CROs, investigator sites, and vendors.
• Prepare, review, and finalize audit reports with observations, risks, and corrective actions.
• Lead development and maintenance of GCP Quality Agreements with partners.
• Maintain GCP audit metrics and reporting for management reviews and readiness.
• Develop and maintain SOPs and quality documents for GCP auditing.
• Manage the internal GCP audit program and effectiveness assessments.
• Support mock inspections and regulatory inspections; respond to findings.
• Provide GCP guidance to cross-functional stakeholders per regulatory requirements.
• Recommend improvements to GCP quality systems and processes.

Skills

Lead Auditor

ICH-GCP knowledge

Regulatory inspections

Audit program management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

None

Job description

Acadia Pharmaceuticals Inc. is seeking a Director, GCP Quality Assurance to lead audit activities across its clinical development portfolio and ensure compliance with global regulatory standards.

The role provides strategic oversight of GCP quality systems, manages audit programs, and supports inspection readiness. The candidate should have 10+ years in pharma, 5+ years in GCP QA, Lead Auditor experience, and strong ICH-GCP knowledge; experience with regulatory inspections is a plus.