Associate Director IT Quality & Compliance

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. 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. You can become part of this exciting journey. 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. Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer! For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl Position Summary Reporting into the Director of IT for the Leiden Cell Therapy Facility (CTF), the Associate Director IT Systems Quality, Compliance & CSV will be primarily responsible for managing IT Quality Systems, deviations, CAPAs, Investigations and Change Management in support of the Leiden Cell Therapy manufacturing site. In addition, the role will be responsible for IT Computer Systems Validation at the Leiden CTF. Key Responsibilities Lead and manage the IT Quality Systems & Compliance team for the Leiden Cell Therapy manufacturing site, in partnership with the business. Take ownership of deviations, CAPAs and investigations involving the Manufacturing Site IT Systems. Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements. Lead and engage with experts as needed to drive continuous improvement and compliance. Support Health Authority and internal audits. Accountable for the continued compliance and Computerized Systems Validation (CSV) of IT systems, procedures and training for CAR-T manufacturing and lab systems. Qualifications & Experience Bachelors in Engineering , IT, Science field or equivalent Minimum 10+ year’s relevant industry experience. Prior Cell Therapy experience is highly valued but not required. Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment. Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians. Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP. Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements. Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices. Demonstrated success working in a high-performing, business results-driven environment. 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. Why You Should Apply Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.