Director, GCP QA & Global Audits Leader

Acadia Pharmaceuticals; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

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

• Lead Auditor experience.
• Deep knowledge of ICH-GCP, FDA and EU regulations.
• Ability to develop SOPs and oversee audit metrics.

Responsibilities

• Plan, schedule, and conduct internal and external GCP audits of CSPs, CROs, investigator sites, and vendors to ensure global regulatory compliance.
• Oversee audit metrics and contribute to SOP development to maintain regulatory standards.

Skills

Lead Auditor

ICH-GCP knowledge

FDA/EU regulatory knowledge

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