End to End Quality Stewardship with external partners - region ZurichJoin a successful global player with innovative products in most attractive indications. In the role of Associate Director you will be the liasing point between external manufacturing partners and internal QA department. Provide end-to-end quality stewardship of assigned Products from manufacturing - to delivery – to warehouse. Act as deputy of 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 ensure that the released batches of the biopharmaceutical products manufactured are manufactured and transported in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). You will provide review of and input to deviations, changes and quality complaints.
You will establish strong relationships with the Quality stakeholder and Senior Management both internally, with partner companies and CMOs.
- B.Sc, M.Sc, PhD in Life Sciences
- > 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
As an ideal candidate you would also have previous experience as Responsible Person (RP) or Deputy RP to apply in a wider scope in this international setting.
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.
Interested? We are looking forward to get in touch with you.