Associate Director, Quality Operations

Acadia Pharmaceuticals•San Diego, CA

11h•Hybrid

About The Position

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 is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Associate Director, Quality Operations plays a critical role in ensuring the quality, compliance, and integrity of Acadia’s clinical and commercial products. This role provides GMP quality oversight for both internal operations and Contract Manufacturing Organizations (CMOs) across all stages of the product lifecycle. The position partners closely with manufacturing and development teams to support reliable supply, regulatory compliance, and continuous improvement in alignment with FDA and global GMP requirements.

Requirements

Bachelor’s degree in Chemistry, Biology, or a related life science
Minimum of 8 years of progressive experience in the pharmaceutical or biopharmaceutical industry
Minimum of 5 years of experience in a Quality Assurance role supporting GMP operations
Demonstrated experience with US FDA and international GMP regulations
Experience overseeing CMOs and outsourced GMP manufacturing activities
Ability to travel up to 15–20%

Responsibilities

Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products
Manage batch review, disposition, and release activities for drug substance and drug product manufacturing and packaging
Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs
Serve as the primary quality interface with CMOs to ensure compliance with SOPs, Quality Agreements, and regulatory expectations
Lead investigations, change control, CAPA activities, and risk assessments related to GMP operations
Support complaint handling activities, including investigation and closure
Support the design, implementation, and maintenance of Acadia’s GMP quality management system in compliance with US and international regulations
Provide on-site GMP quality support at CMOs, including participation in audits and inspections as required
Represent Quality Assurance on cross‑functional GMP manufacturing, packaging, supply chain, and development teams
Other duties as assigned