QA Manager Operations
vor 2 Wochen
QA Manager Operations Duration : 1 / 10 / 2025 - 30 / 09 / 2026 Location : Basel, CH Support a discipline and / or provide a service individually or within a team of associates. May provide functional expertise to the corresponding business partner (Line Unit) and other QA Units in area of responsibility Write, review, decide on approval and / or release of GMP‑relevant deliverables in order to ensure compliance with cGMP internal quality standards. Perform project related activities, e.g. TRD products portfolio, operational processes, Quality Risk Assessments. Support Project management functions as a project team member. Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.). Specific Activities Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation with the authority defined as per related governing SOPs, and with authorities delegated by the TRD Quality Team Head or QA Switzerland Site Head (FvP) Oversight on the review of master and executed batch records performed by the QA specialists, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up. Write, review, and complete GMP relevant documents (e.g. CoAs, BRR checklists, SOPs, risk assessments). Supports audits and inspections in case of questions on assigned projects QA SPOC for assigned CMO - in this context, supports on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements. Also responsible for collecting feedback from the various QA managers and support preparation of the Quality Risk Assessment (QRA). Is informed about deviations / OOX, general issues and changes at the CMO, and follows up at the corresponding meetings. Helps the QA managers and specialists for specific questions on CMO batch records / documentation and helps keeping harmonization of TRD QA Ops response. Deputize for peers in the same area of responsibility Key Requirements Experience in a technical R&D environment (pharma / chemical) is preferred. Education (desirable) : Masters (5 years in pharma quality) Fluent German and English required (oral & written) Good knowledge of cGMP, working knowledge in technical development, production and QA. Sound scientific, technical and regulatory knowledge. Strong organizational and decision‑making skills. Strong and proven ability to analyze and evaluate cGMP compliance. On-site presence required The candidate must hold a EU passport or valid Swiss work permit SThree_Germany is acting as an Employment Business in relation to this vacancy. #J-18808-Ljbffr
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