Director, GCP QA & Audit Leadership

ACADIA Pharmaceuticals Inc.; Princeton (NJ); On-site; USD 166,000 - 207,000; Full time

Benefits offered by this job

Competitive base salary

Healthcare: Medical, dental, vision

Employer-paid life, disability, travel

401(k) with match

Employee Stock Purchase Plan

Vacation days: 15+

Paid holidays: 13-15

Paid sick time: 10 days

Parental leave

Tuition assistance

Job summary

ACADIA Pharmaceuticals Inc. in Princeton, NJ, seeks a Director, GCP Quality Assurance to lead audit activities across our clinical development portfolio and ensure compliance with FDA, ICH-GCP, EU regulations.

You will manage internal and external audits, develop quality agreements, SOPs, and maintain audit metrics to support inspection readiness and continuous improvement. Requires a Bachelor's in Life Sciences, 10+ years in pharma/biotech, 5+ years in GCP QA with Lead Auditor experience; SQA

Qualifications

• 10+ years of experience in the pharmaceutical/biotech regulated industry.
• 5+ years of direct experience in GCP Quality Assurance and auditing.
• Lead Auditor experience for internal and external GCP audits.
• Strong knowledge of ICH-GCP, FDA, EU, and international GCP regulations.
• Experience auditing CROs, investigator sites, vendors, and GCP service providers.
• Experience supporting regulatory inspections and inspection readiness.

Responsibilities

• Plan, schedule, conduct, and manage internal and external GCP audits of CSPs, CROs, investigator sites, and supporting vendors to ensure compliance with company standards and global GCP regulations
• Prepare, review, and finalize audit reports, ensuring observations, risks, and corrective actions are documented and appropriately tracked to resolution
• Lead the development, review, and maintenance of GCP Quality Agreements with CROs, CSPs, and other clinical study partners
• Maintain GCP audit metrics and deliver quality and compliance reporting to support management reviews, inspection readiness, and continuous improvement initiatives
• Develop, review, and maintain SOPs and quality documents supporting GCP auditing and compliance activities
• Manage the internal GCP audit program, including audit planning, execution, follow-up activities, and effectiveness assessments
• Support mock inspections, regulatory inspections, and responses related to GCP studies and quality systems
• Provide GCP compliance guidance and oversight to cross-functional stakeholders while ensuring adherence to FDA, ICH, EU, and other applicable global regulatory requirements
• Recommend and implement improvements to GCP quality systems, processes, and procedures to strengthen compliance and operational effectiveness
• Other duties as assigned

Skills

GCP Quality Assurance

Lead Auditor

Audit Management

FDA/ICH/GCP regulations

CRO/Vendor Audits

Education

Bachelor's degree in Life Sciences or related field

Job description

ACADIA Pharmaceuticals Inc. in Princeton, NJ, seeks a Director, GCP Quality Assurance to lead audit activities across our clinical development portfolio and ensure compliance with FDA, ICH-GCP, EU regulations.

You will manage internal and external audits, develop quality agreements, SOPs, and maintain audit metrics to support inspection readiness and continuous improvement. Requires a Bachelor's in Life Sciences, 10+ years in pharma/biotech, 5+ years in GCP QA with Lead Auditor experience; SQA