Associate Director, GLP​/GCP Quality Audits and Compliance

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.

At Acadia, we're here to be their difference.

Please note that this position can be based in San Diego, CA OR Princeton, NJ OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

The Associate Director, GLP/GCP Quality Audits and Compliance plays a critical role in protecting data integrity and regulatory readiness across the company's nonclinical and clinical portfolio. This position leads the planning, execution, and reporting of internal and external GLP/GCP audits, ensuring compliance with U.S. and international regulations while driving continuous improvement in quality systems.

As a trusted quality partner, this role provides expert guidance on GLP/GCP compliance, supports regulatory inspections, and works closely with internal teams and Contract Service Providers (CSPs) to maintain inspection-ready operations. The ideal candidate brings strong audit leadership, sound regulatory judgment, and the confidence to influence quality practices across the organization.

• 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

• Bachelor's degree in Life Sciences or a related scientific/technical discipline. An equivalent combination of education and applicable job experience may be considered
• Targeting 8+ years of progressively responsible experience within quality assurance (QA), including 5+ years directly responsible for GLP/GCP QA, with direct experience leading external and internal audits
• Extensive knowledge of guidelines and international regulations that affect the GLP/GCP QA programs
• Society for Quality Assurance (SQA), American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus

• Thorough knowledge of quality management best practices within the pharmaceutical, biopharmaceutical, or other regulated industries
• Demonstrated expertise in quality assurance activities and ICH, FDA, EU, and international GLP/GCP regulations as they apply to nonclinical and clinical studies
• Proven ability to interpret and apply GLP/GCP regulations, including U.S. and global requirements
• Hands‑on experience…