Manager, QC Systems and 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. 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 Bristol Myers Squibb is seeking a Manager, QC Investigations for the Quality Control organization at the Cell Therapy Facility (CTF) in Leiden, The Netherlands. This role is responsible for leading a team charged with performing QC high impact deviations, laboratory investigations, and CAPAs in accordance with BMS policies, standards, procedures and regulatory requirements. The Manager will be responsible for hiring and developing a high performing team and will drive the QC Investigation and CAPA program performance, reporting metrics and continuous improvement progress. This role is stationed in Leiden and reports to the Head of QC Systems. Key Responsibilities Hire, train, mentor and develop the team members to support the business operations and employee career development. Establish and communicate performance objectives that are consistent with company goals and objectives. Manage QC deviation and CAPA program, driving closure of QC high impact deviations, laboratory investigations, and CAPAs. Establish and maintain KPIs to ensure timely and compliant deviation and CAPA closure. Perform review of deviation and investigation reports, as well as review and approval of site and department SOPs related to investigations. Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment to enhance unit performance and integration across site departments. Collaborate with cross functional areas to develop training curricula related to investigations and provide training to new lead investigators. Experience: Experience in building and growing an organization into a high performing team. Strong background and demonstrated effectiveness in laboratory or biomanufacturing investigations and root cause analysis techniques. Knowledge of cell therapy analytical and microbiological testing is highly desirable. Knowledge of US and EU cGMP regulations and health authority inspections. Demonstrated leadership, interpersonal, communication, and motivation skills. Advanced ability to communicate effectively with peers, department management and cross-functional peers. 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.