Director, GCP Quality Assurance

The posting, as Acadia Pharmaceuticals Inc. wrote it

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.

Position Summary

The Director, GCP Quality Assurance is responsible for leading Good Clinical Practice (GCP) audit activities across Acadia's clinical development portfolio to ensure compliance with applicable global regulatory requirements and internal quality standards. This role provides strategic oversight of GCP quality systems, manages audit programs, supports inspection readiness initiatives, and serves as a subject matter expert on GCP compliance.

Primary Responsibilities

• Plan, schedule, conduct, and manage internal and external GCP audits of Contract Service Providers (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

Education and Experience

• Bachelor's degree in Life Sciences or a related scientific discipline, or an equivalent combination of education and relevant experience
• 10+ years of experience within the pharmaceutical, biotechnology, or related regulated industry
• 5+ years of direct experience in GCP Quality Assurance, compliance, and auditing functions
• Demonstrated experience serving as a Lead Auditor for internal and external GCP audits
• Strong

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m, or any basis protected under federal, state or local law.

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