Associate Director, Quality Operations
Acadia Pharmaceuticals Inc.About the role
<div class="content-intro"><p></p> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow"><strong data-ogsc="" data-olk-copy-source="MessageBody">About Acadia Pharmaceuticals</strong></span></div> <div data-ogsc="black"> </div> <div data-ogsc="black"><span data-ogsc="" data-ogsb="yellow">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.</span></div></div><p><strong>Please note that this position is based in San Diego, CA or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.</strong></p> <p> </p> <div> <h3>Position Summary</h3> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol">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.</div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"> <div> <h3>Primary Responsibilities</h3> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Provide GMP quality oversight for internal operations and CMOs supporting clinical and commercial products</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Manage batch review, disposition, and release activities for drug substance and drug product manufacturing and packaging</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Lead QA oversight of technology transfer, process validation, registration batches, deviations, and process changes at CMOs</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Serve as the primary quality interface with CMOs to ensure compliance with SOP
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