Senior Manager QA, EU Qualified Person Cell Therapy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. 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. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

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
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.

Duties/Responsibilities

Include, but are not limited to, the following:

• 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
• Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment and the batch disposition process in the EU/EEA and Rest of World Markets as applicable.
• 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 correct