Sr. Manager, Quality Assurance

<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><div> <h1><span style="font-size: 10pt;">Position Summary:</span></h1> <p><span style="font-size: 10pt;">On behalf of Acadia GmbH the Sr. Manager, Quality Assurance Operations will be responsible for oversight of cGMP European operations within a global Quality Assurance department of Acadia Pharmaceuticals Inc. Responsibilities will include oversight of assigned cGMP operations performed at Contract Manufacturing Organizations (CMOs), as well as cGMP European operations performed at Acadia, quality release of API and drug product, raw materials and intermediates intended for commercial and clinical (where required) use. Primary responsibilities include: batch record review and batch disposition, support of product complaints, annual product review / product quality reviews, continuous process verifications (CPV), ensuring conformance to global Acadia standard operating procedures (SOPs) and quality agreements with CMOs, as well as compliance to Swissmedic/EMA/MHRA and other applicable international regulations. Proficient-level user and participant in continuous improvement activities with respect to Acadia global GMP training program, change management, validation activities, batch review and release, complaint handling, CAPA program, GMP audits, and similar related activities. This position reports to the Director, Quality Assurance, Acadia GmbH.</span></p> <h1><span style="font-size: 10pt;">Primary Responsibilities:</span></h1> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Manages the Acadia batch disposition process of API, Drug Product, Raw materials and Intermediates</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participates in design, implementation and management of the Acadia GMP quality management system, based on Swissmedic/EMA/MHRA and other applicable international regulations</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ensures compliance of the Acadia GMP quality management system with Swissmedic/EMA/MHRA and applicable international quality management system regulations</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participates in GMP supplier audits and Acadia documentation control systems as needed</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Manages and/or provides oversight to QA personnel involved with CMO technology transfer, process validation, batch documentation, registration batch review and process changes and deviations</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participates in the review of, and ensures conformance to Quality Agreements with GMP contract service providers for outsourced operations</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Manages internal investigations and change management and establishes effective CAPA plans and ensure oversight on CMOs investigation and change management activities.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participates in and/or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ensures adequate QA representation on all GMP product development teams; provides direction to QA representatives on these teams</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participates in Quality Operations functions such as: Material Review Board, quality board, strategic planning efforts, etc., as may be required</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Participates in formal risk assessment activities as required</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Develops and/or contributes metrics to support product and/or process review efforts as needed</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Develops department goals and objectives for senior management review in alignment with Acadia strategic planning</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Other duties as assigned/required</span>                                                  </li> </ul> </div> <h1><span style="font-size: 10pt;">Education/Experience/Skills:</span></h1> <p><span style="font-size: 10pt;">Pharm D, Master´s or Bachelor’s degree in Chemistry/Biology/Pharmacy or related life science is required. A minimum of 5 years related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry.</span></p> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Demonstrated knowledge of Quality Assurance activities and International Conference on Harmonization (ICH) and Swissmedic/EMA/MHRA and other international GMP regulations as they relate to clinical trials, product development, commercial requirements and technology transfer</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Demonstrated proficiency in interpretations of cGMP regulations for Swissmedic/EMA/MHRA and other international regulations.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience implementing and managing quality management systems is an advantage</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Experience conducting internal and supplier audits and manufacturing facility inspections is an advantage</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Ability to interpret and relate Quality standards for implementation and review</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Able to gain cooperation of others</span></li> <li style="font-size: 10pt;"><s