Jobid=93b1ca322200 (0.0273)
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Bristol Myers Squibb Netherlands Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands. The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. Check out this video if you want to know more about it! The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team. For more information about Bristol Myers Squibb Netherlands, visit us at bms.The Senior Manager EU QP supports in the implementation and execution of the Quality Assurance function and Quality Management System of BMS Netherlands Operations BV which will ensure product quality and compliance with all regulatory and corporate requirements for Investigational and Commercial ATMP (Cell Therapy) Products within Europe and Rest of World Markets as applicable. This position acts in its primary role as Qualified person for investigational and commercial Cell Therapy products within EU/EEA and Rest of World Markets as applicable. These duties and responsibilities are executed in accordance with the requirements of the BMS Netherlands Operations BV license and the Professional Code of Conduct. Act as Qualified Person as per requirements of BMS Netherlands Operations BV licences and execute functions in accordance with Professional Code of Conduct Fulfil Qualified Person duties as defined in article 51 of 2001/83/EC, Annex 16, Annex 13 and the ATMP guidelines of Volume 4 of the EU GMP guidelines Perform the verification of QP certification of imported Advanced Therapy Medicinal Products (ATMPs) Investigational Medicinal products (IMP) into the United Kingdom in accordance with MHRA guidelines Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain, as assigned Build up a deep knowledge of the cell therapy-based processes, technology and the specific treatments which are intended to be commercialized Interact with global, site, and vendor oversight Quality and Supply Chain functions to ensure a compliant, efficient, and timely batch disposition for cell therapies Participate in GMP- or GDP-related health authority inspections at Celgene Distribution BV, BMS Netherlands Operations BV and other BMS entities as required, respond to any noted observations, and ensure implementation of corrective actions Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken Develop and maintain a release process which takes into account the specifics of autologous cell therapy treatments with staged release, treatment of OOS results and related risk assessments Conduct final review and approval of non-routine quality investigations related to batch deviations, batch disposition, and other quality systems for assigned products as required Identify and recommend product and process quality improvements Support BMS Netherlands Operations BV for implementing and maintaining and continuously improving the quality management system Maintain compliance with personal training requirements Draft or review, negotiate with contractors, and recommend approval for Quality Agreements The Senior Manager QA, EU QP Cell Therapy reports administratively and functionally to the Director, Disposition Operations – Cell Therapy MSc (or equivalent) in a technical or scientific discipline and meets educational requirements for EU Qualified Person as described in Article 49 2001/83/EC and any national requirements Eligible to act as Qualified Person within EC/EEA Extensive quality assurance/control experience in the biotechnology industry (equivalent to a minimum of 8 years experience), including audit, batch record review, change control, complaint handling and investigations experience Must have experience and good knowledge of aseptic manufacturing, biological products and/or cell therapy products Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach Must have excellent organizational, project management and problem solving skills Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (EU particularly), including a good knowledge of Advanced Therapy Medicines Product guidelines of the EU GMP Vol. Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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