Director, GCP QA — Lead Global Audits & Compliance

ACADIA Pharmaceuticals Inc.; San Francisco (CA); On-site; USD 140,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Employer-paid life, disability, travel

401(k) Plan with company match

Employee Stock Purchase Plan

Job summary

Acadia Pharmaceuticals Inc. in San Francisco seeks an experienced Director to lead GCP Quality Assurance across its clinical development portfolio.

You will ensure compliance with global regulatory requirements and internal standards, and provide strategic oversight of GCP quality systems. Responsibilities include managing audit programs, preparing reports, maintaining quality agreements, and driving improvements with cross-functional teams to support inspection readiness and regulatory

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years in pharma/biotech regulated industry.
• 5+ years in GCP QA, compliance and auditing.
• Lead Auditor experience for internal/external audits.
• Strong knowledge of ICH-GCP, FDA and international regulations.

Responsibilities

• Plan, conduct, and manage internal and external GCP audits of CSPs, CROs, sites and vendors.
• Prepare and finalize audit reports with observations and corrective actions.
• Develop and maintain GCP Quality Agreements with partners.
• Maintain audit metrics and support inspection readiness and improvement.
• Develop and maintain SOPs and quality documents for GCP activities.
• Oversee the internal GCP audit program including planning, execution and follow-up.
• Support mock/regulatory inspections and responses related to GCP.
• Provide GCP guidance to cross-functional stakeholders per global requirements.

Skills

Lead Auditor

GCP Compliance

ICH-GCP Knowledge

FDA/EU Regulations

Audit Management

Education

Bachelor's degree in Life Sciences

Tools

GCP Quality Systems

Job description

Acadia Pharmaceuticals Inc. in San Francisco seeks an experienced Director to lead GCP Quality Assurance across its clinical development portfolio.

You will ensure compliance with global regulatory requirements and internal standards, and provide strategic oversight of GCP quality systems. Responsibilities include managing audit programs, preparing reports, maintaining quality agreements, and driving improvements with cross-functional teams to support inspection readiness and regulatory