Manager AOP, QA Shop Floor
Bristol-Myers Squibb
- Location
- Leiden – NL
- Work model
- On-Site
- Level
- Mid
- H-1B history
- 57 approvals (FY2023)
- Posted
- 2h ago
About this role
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 Aseptic Observation Manager supports Cell Therapy manufacturing by providing expert oversight and feedback on aseptic techniques and cleanroom behaviors for operators, verifiers, and support personnel. This role is central to sustaining the behaviors defined in the site’s Contamination Control Strategy and reducing the potential for personnel ‑ driven contamination risks. Working closely with Manufacturing, Quality Assurance, Training, and Sterility Assurance, the Manager elevates aseptic performance and reinforces a strong quality culture. The role identifies behavior drift, delivers real ‑ time coaching, and ensures observations are accurately documented and trended to drive meaningful improvement. In addition, the Manager contributes to deviation investigations, change control evaluations, GEMBA walks, and broader sterility assurance activities. They also support the setup, governance, and continuous improvement of the Aseptic Observation Program to ensure consistent, risk ‑ based oversight across cleanroom operations. Duties/Responsibilities: Leadership & Program Governance Provide informal and indirect leadership for the Aseptic Observer team, supporting the team lead with oversight, planning, scheduling, and program development. Assist in setting up, structuring, and operationalizing the AOP, including procedure creation, qualification pathways, observation tools, and governance mechanisms. Ensure site-level alignment with global AOP standards, Annex 1 expectations, and CCS principles. Drive continuous improvement of the program through stakeholder feedback, observations data, and regulatory trends. Aseptic Observations & Coaching Perform and support aseptic observations on the manufacturing floor to evaluate operator behaviors, aseptic technique, gowning, and cleanroom conduct. Provide real ‑ time coaching when appropriate and escalate issues following deviation and triage SOPs. Document