Acadia Pharmaceuticals is seeking an Associate Director, GLP/GCP Quality Audits and Compliance to protect data integrity and regulatory readiness across the company’s nonclinical and clinical portfolio.
Requirements
- Plan, schedule, coordinate, and conduct internal and external GLP/GCP and GCP audits of company functions and Contract Service Providers (CSPs) in accordance with company standards and global regulatory requirements
- Own the end-to-end audit lifecycle, including audit preparation, execution, documentation, reporting, follow-up, and verification of corrective and preventive actions
- Prepare, review, and approve clear, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolved
- Develop, review, and maintain GLP/GCP quality agreements, SOPs, and related quality documentation supporting nonclinical and clinical activities
- Maintain, manage, and continuously improve the internal GLP/GCP audit program, ensuring ongoing inspection readiness
- Compile, analyze, and trend audit metrics to support management review, quality oversight, and regulatory inspections
- Serve as a GLP/GCP subject matter expert, partnering with internal and external stakeholders (e.g., laboratory leadership, study directors, regulatory affairs, CSPs) to ensure consistent regulatory compliance
- Support internal audits, mock inspections, and regulatory inspections, recommend policy and process improvements with company-wide impact, and ensure adherence to company policies, including Privacy/HIPAA and other applicable legal and regulatory requirements
- Other duties as assigned
Benefits
- Competitive base salary
- Discretionary bonus
- Equity awards
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
