Stellenbeschreibung

GxP Compliance Manager (m/f)Alexion is a biopharmaceutical company focused on serving patients with severe and rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Alexion is evaluating other potential indications for its marketed drug and is developing additional highly innovative biotechnology product candidates across multiple therapeutic areasSolid Line Reports to: Director Regional Quality Assurance, Corporate QualityDotted Line Reports to: Pharmaceutical Affairs Manager, German AffiliateLocation: Munich, GermanyPosition Summary The Site GxP Compliance Manager will be responsible for managing the implementation and execution of the Corporate Quality System at designated affiliate(s) within Alexion. The candidate will be the primary Quality contact in their specific designated region, and will have strong experience in GxP’s, quality systems and Pharmacovigilance areas as well as the ability to function independently and in a matrix environment. Principal ResponsibilitiesIn coordination with their Director Regional Quality Assurance, the other Site GxP Compliance and related peers within the Global Quality organization, the Site GxP Compliance Manager will work to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards at the site levelImplement and maintain a GxP compliant QMS in the AffiliatePerform the duties of the Responsible Person for Wholesale in Germany in accordance with AMG (German Drug Law) §52a and to AM-Handels-V (Law on Wholesale)Manage GxP related tasks including, but not limited to:Returns managementRecall managementCustomer ComplaintsDeviationsChange ControlCAPARegulatory Authority Interaction under the direction of the PAMSelf-InspectionTrainingManagement reviewBusiness continuityProvide leadership and resource management support to Corporate Quality and their designated AffiliateEnsure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local, GDP and PV guidelines.Provide internal auditing resource to assess site compliance on a regular basisEnsure Alexion is kept fully informed of new or emerging GDP and regulatory changes in their region.Manage the review and implementation of Quality Improvement/remediation plans for their Affiliate identified through Corporate as well as internal GDP/PV auditsProvide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activitiesIn collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriateMonitor, GDP and Pharmacovigilance compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate QualityAct as Quality liaison between the local operational groups and Corporate Quality for GDP/PV functions and activities.Partner with local, regional and global operational groups to foster a proactive approach to compliance.Qualifications5 years+ of hands-on Quality Assurance / Compliance and management experience in pha