Director, GCP Quality Assurance & Audit Leader

Acadia Pharmaceuticals; Princeton (NJ); Sur place; USD 166 000 - 207 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

Equity awards

401(k) match

Employee Stock Purchase Plan

Paid time off

Parental leave

Résumé du poste

Acadia Pharmaceuticals is seeking a Director of GCP Quality Assurance to lead audit activities across the clinical development portfolio, ensuring compliance with global regulations and internal standards. The role provides strategic oversight of GCP quality systems, manages audit programs, and supports inspection readiness.

The successful candidate will have 10+ years in pharma/biotech, 5+ years in GCP QA, and strong ICH-GCP knowledge, with experience auditing CROs and sites.

Qualifications

• Bachelor's degree in Life Sciences or related discipline.
• 10+ years of experience within the pharmaceutical/biotech industry.
• 5+ years in GCP Quality Assurance, compliance, and auditing functions.
• Demonstrated experience as Lead Auditor for internal and external GCP audits.
• Strong knowledge of ICH-GCP and FDA/EU regulations.
• Experience auditing CROs, investigator sites, vendors, and other GCP providers.

Responsabilités

• Plan, schedule, conduct, and manage internal and external GCP audits of CSPs, CROs, 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 support management reviews and inspection readiness.
• Develop and maintain SOPs and quality documents supporting GCP activities.
• Manage the internal GCP audit program, including planning, execution, follow-up, and effectiveness assessments.
• Support mock inspections, regulatory inspections, and responses related to GCP studies.
• Provide GCP compliance guidance to cross-functional stakeholders per regulatory requirements.
• Recommend improvements to GCP quality systems and processes.

Connaissances

GCP Quality Assurance

Lead Auditor

Regulatory Compliance

Cross-functional Collaboration

Formation

Bachelor's degree in Life Sciences

Description du poste

Acadia Pharmaceuticals is seeking a Director of GCP Quality Assurance to lead audit activities across the clinical development portfolio, ensuring compliance with global regulations and internal standards. The role provides strategic oversight of GCP quality systems, manages audit programs, and supports inspection readiness.

The successful candidate will have 10+ years in pharma/biotech, 5+ years in GCP QA, and strong ICH-GCP knowledge, with experience auditing CROs and sites.