Gloor&Lang AG Baden, Aargau, Switzerland
17 Jul, 2019Unbefristet
QA Manager Biopharmaceuticals - BIG PHARMA End to End Quality Stewardship with external partners - region Zurich Come on board for one of the most successful biopharmaceutical companies worldwide. Our customer has an extensive product portfolio, which includes various biotechnologically manufactured active pharmaceutical substances (drug substance) and various galenical technologies for drug product, especially Steriles. Growing volumes result in an increased complexity of the processes. We seek for a QA Manager who can provide expertise in being a reliable point of contact from Quality side on the Product Operational Team and provide end-to-end quality stewardship of assigned Products from manufacturing - to delivery - to warehouse. Your will act as Deputy of the Responsible Person (FvP), ensuring, that all external manufactured batches from drug substance- drug product - primary packaging - secondary packaging to warehouse shipping meet the set specifications. In collaboration with the Product Operations Team you provide review and input to product specific deviations, changes and quality complaints. You will also participate in local and global quality and business related meetings to ensure alignment of activities and provide support to the Quality Operations and to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science and Technology teams in support of projects, technical transfers programs, supplier selection programs, etc. You will establish strong relationships with the Quality stakeholder and Senior Management both internally, with partner companies and CMOs. Your profile: B.Sc, M.Sc, PhD in Life Sciences 3-5 years of experience in Pharma QA and/or Operations - strong preference for Biologics Sound expert knowledge of GMP documentation requirements and batch release process Smooth collaboration with Partner Companies and numerous CMOs German language skills B2 level upwards Strong interpersonal communication, collaborative and leadership skills in dealing with a broad variety of cultures. You have demonstrated the ability in technical writing are able to work in a matrix organization in virtual international environment. Act as a quality influencer throughout all steps in the multi-site supply network and show your talent in building trustful and effective relationships.