Position Summary:

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.

Primary Responsibilities:

• Oversee CMO’s from a quality perspective as assigned and perform review and approval of CMO Quality Documentation.


• Manages the Acadia batch disposition process of API, Drug Product, Raw materials and Intermediates


• Participates in design, implementation and management of the Acadia GMP quality management system, based on Swissmedic/EMA/MHRA and other applicable international regulations


• Ensures compliance of the Acadia GMP quality management system with Swissmedic/EMA/MHRA and applicable international quality management system regulations


• Serves as a key point of contact with CMO partners and ensures integrated, coordinated activities related to cGMP production and continuous improvement


• Participates in GMP supplier audits and Acadia documentation control systems as needed


• 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


• Participates in the review of, and ensures conformance to Quality Agreements with GMP contract service providers for outsourced operations


• Manages internal investigations and change management and establishes effective CAPA plans and ensure oversight on CMOs investigation and change management activities.


• Participates in and/or leads QA in continuous improvement of Acadia quality management systems according to GMP and current industry standards


• Ensures adequate QA representation on all GMP product development teams; provides direction to QA representatives on these teams


• Recommends changes to policies and establishes procedures that affect the functional area and may also have company-wide effect


• Participates in Quality Operations functions such as: Material Review Board, quality board, strategic planning efforts, etc., as may be required


• Participates in formal risk assessment activities as required


• Develops and/or contributes metrics to support product and/or process review efforts as needed


• Develops department goals and objectives for senior management review in alignment with Acadia strategic planning


• Other duties as assigned/required