Quality Control Manager

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QUALITY CONTROL MANAGER Duration: 9 Months

Location: Zurich, Switzerland As the Quality Control Manager, your primary duties are focused around non-laboratory support of the QC functions. You will have the responsibility for operational, technical and compliance oversight for the Global Small Molecule Quality Operating Unit (OpU).Quality Control (QC) release and stability testing performed at external service providers (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products as part of the global QC functionCreate, maintain analytical documentations, e.g. protocols, specifications, methods, reports, etc.Directly manage relationships with external testing partners to ensure continuity of testing, investigation and resolution of unexpected results, as well as representing the company in interactions with providersCompile and monitor performance metrics and support continuous improvement of activities within QC organizationSupport analytical and manufacturing investigations of unexpected results to identify root cause and define and implement corrective or preventive actionsWork closely with Quality OpU leadership to support the forecast of future spend, monitoring variances, and support improvements with financial benefit.Provide support to data analysis, data entry, purchase order creation/reconciliation and financial oversight of third party labs in Europe and other regions as required by the third party lab locations.Support compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assures execution to requirements.Support regulatory filing and product APQR. RESPONSIBILITIESAct as deviation/Lab investigation owners, support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help drive to closure in timely manner.Collate and report out third party lab performance metrics.Provide analytical support to assigned products. Responsible for AR, APQR, regulatory filings, RTQs, etc of managed products.Support the financial oversight of third party labs to assure budget requirements are met and is accountable for the CTL financial processes execution (ie. PO generation, invoice processing, etc.) of the Global Quality Control unit.Work with the Head of QC, QC Business Operations Lead and QC Strategy and Business Operations to provide input on financial estimates and assumptions.Develop testing plans and support method transfers as neededManage stability study protocol development, execution, data analysis and reporting for OpU products as designatedConstitute to data summary and communication tools such as dashboards, reports and product quality review.Support continued business process improvement activities.Cultivate and maintain relationships with key internal and external customers.Initiate Change Controls to support change of vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records.Be a valued partner by providing actionable decision support (e.g. what-if scenarios for decision making).Provide technical support to other QC activities as business needs arises.Maintain training records current and GMP compliance. EDUCATION / EXPERIENCEBachelor's Degree in Chemistry, Biology, or related scientific discipline.8 + years' experience in in the pharmaceutical industry and/or QA/QC laboratory environment.Must have good understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques. Must have experience in analytical investigations, handling of OOS, OOT investigations.Experience in API and oral solid dosage is a plus.Experience in analytical laboratory, method execution, qualification and/or validation of small molecule or biologics assays.General knowledge and experience of Pharmaceutical and Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products)Experience in regulatory support, authoring dossier sections, respond to regulatory inquires.Strong communication and technical writing skills.Cross functional and matrix management experience.Awareness of financial processes.Project management experience.General understanding of applicable regulations and guidance's.Strong proficiency in Microsoft tools, especially Word and Excel.Knowledge of Laboratory Information Systems (LIMs). Sthree Switzerland is acting as an Employment Business in relation to this vacancy.