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 knowledge of ICH-GCP guidelines and applicable FDA, EU, and international GCP regulations
Experience auditing CROs, investigator sites, vendors, and other GCP service providers
Experience supporting regulatory inspections and inspection readiness activities
Ability to interpret and apply global GCP regulations to quality systems and clinical trial operations

Preferred Qualifications

SQA, ASQ, or Lead Auditor certification
Experience conducting global audits across US, EU, UK, Japan, and other international regions
Experience with clinical service providers and supporting functions such as eCOA, computerized system validation (CSV), and data management

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule and/or business priorities.