Senior GCP QA Director – Audits, Compliance & Readiness

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Employee stock purchase plan

Paid holidays

Job summary

Acadia Pharmaceuticals seeks a Director, GCP Quality Assurance to lead GCP audit activities across its clinical development portfolio, ensuring compliance with global regulations and internal standards.

The role provides strategic oversight of quality systems, manages audit programs, and supports inspection readiness. It requires 10+ years in pharma/biotech with GCP QA and Lead Auditor experience, plus strong ICH-GCP knowledge.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10+ years in pharmaceutical/biotech with GCP/QA auditing experience.
• 5+ years leading GCP QA or auditing programs.

Responsibilities

• Plan, conduct, and manage internal and external GCP audits of CSPs, CROs, sites, and vendors.
• Prepare, review, and finalize audit reports with observations and corrective actions.
• Develop and maintain GCP Quality Agreements with partners.
• Maintain GCP audit metrics and produce quality reports for management reviews.
• Develop and maintain SOPs and quality documents supporting GCP auditing.
• Lead the internal GCP audit program including planning, execution and follow-up.
• Support inspections and responses related to GCP studies and quality systems.
• Provide GCP guidance to cross-functional stakeholders in line with FDA, ICH, EU regulations.
• Recommend improvements to GCP quality systems and processes.

Skills

GCP knowledge

Audit leadership

Regulatory understanding

Cross-functional liaison

Education

Bachelor's degree in Life Sciences

Tools

eCOA systems

CSV familiarity

Job description

Acadia Pharmaceuticals seeks a Director, GCP Quality Assurance to lead GCP audit activities across its clinical development portfolio, ensuring compliance with global regulations and internal standards.

The role provides strategic oversight of quality systems, manages audit programs, and supports inspection readiness. It requires 10+ years in pharma/biotech with GCP QA and Lead Auditor experience, plus strong ICH-GCP knowledge.