Sr. Manager Quality Control, EU

<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>Position Summary:</strong></p> <p>The Sr. Manager, Quality Control EU plays a key role in the quality direction of analytical methods and specifications used to test and release Acadia’s products outside North America. This position is responsible for the establishment of commercial analytical methods used to support manufacturing, release, and stability testing that is conducted at multiple Acadia drug substance (DS) and drug product (DP) Contract Service Providers (CSPs) as well as the review of analytical method validations/transfers between laboratories outside North America. The role is responsible for the analytical review of release testing and stability data of DS and DP and coordinates efforts with CSPs to report and trend analytical test results in a timely manner. The position supports the quality review of analytical technical reports and documents intended for regulatory submissions.</p> <p><strong>Primary Responsibilities:</strong></p> <ul> <li>Review and approve analytical test results for DS and DP</li> <li>Review and/or author analytical method protocols, validations and analytical sections of annual product quality reviews for commercial products</li> <li>Review and/or author analytical transfer protocols and reports between laboratories</li> <li>Author stability protocols and reports</li> <li>Negotiate stability related agreements</li> <li>Actively monitor stability programs at CSPs</li> <li>Author and/or review analytical data summaries to support batch release and stability assessments</li> <li>Assist in the review of reports for regulatory filings</li> <li>Support and participate as needed during inspections of local health authorities</li> <li>Direct CSPs to facilitate stability testing at contract laboratories for Acadia projects</li> <li>Coordinate stability studies including reporting of test results</li> <li>Report stability data/trending to senior management</li> <li>Liaises with manufacturing, quality and regulatory counterparts to develop stability protocols for regulatory submissions</li> <li>Liaises with project teams to identify intermediates, DS and DP batches required to be added to stability programs</li> <li>Conduct and document analytical deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and CAPA reports following SOPs and GMP guidelines</li> <li>Lead analytical data review at CSPs</li> </ul> <p><strong>Education/Experience/Skills</strong></p> <ul> <li>Bachelor’s degree in a Health Science discipline required, Master’s degree preferred. Equivalent combination of relevant education and applicable job experience will be considere