Global GCP QA Director — Audit & Compliance Leader

Regulatory Jobs; Princeton (NJ); Sur place; USD 166 000 - 207 000; Plein temps

Avantages offerts par ce poste

Competitive base, bonus, new hire and;

Medical, dental, and vision insurance

Employer-paid life, disability, travel

401(k) Plan with 1:1 match up to 5%

Employee Stock Purchase Plan with 2‑yr

15+ vacation days

13-15 paid holidays

10 days paid sick time

Paid parental leave

Tuition assistance

Résumé du poste

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

You will oversee audit programs, develop quality agreements, track findings, support inspections, and guide teams on FDA/ICH/EU requirements, contributing to continuous improvement.

Qualifications

• Candidate has a Life Sciences degree with 10+ years in pharma/biotech.
• 5+ years leading GCP QA, auditing, and compliance activities.
• Experience serving as a Lead Auditor for internal and external audits.

Responsabilités

• Plan, schedule, conduct, and manage GCP audits of CSPs, CROs, sites and vendors.
• Prepare, review, and finalize audit reports with observations and corrective actions.
• Develop, review, and maintain GCP Quality Agreements with partners.
• Maintain GCP audit metrics and quality reporting for management reviews.
• Develop and maintain SOPs and quality documents for GCP activities.
• Oversee internal GCP audit program, including planning and follow-up.
• Support mock and regulatory inspections and responses related to GCP.
• Provide GCP guidance to cross-functional stakeholders per FDA/ICH/EU.

Connaissances

GCP auditing

Lead Auditor

Regulatory knowledge

Inspection readiness

Cross-functional leadership

Formation

Bachelor's in Life Sciences or related

10+ years pharma/biotech experience

5+ years GCP QA/auditing

Outils

eCOA

CSV

Data management

Description du poste

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

You will oversee audit programs, develop quality agreements, track findings, support inspections, and guide teams on FDA/ICH/EU requirements, contributing to continuous improvement.