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Senior Specialist QC Investigations & Compliance

Leiden, Netherlands

Job Description

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 rich in diversity. 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: .

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 or

Position Summary

Are you interested in improving QC processes related to its quality (output) and efficiency? Then this job is something for you!

The Senior Specialist QC Investigations and Compliance serves as the QC representative and will author and review Compliance related topics like Deviations, Lab Investigations, CAPAs and Change Controls. You will cover the full QC and will be collaborating with multiple departments within BMS.

The unique opportunity at this moment is to be able to help build the Leiden Deviation/Lab investigation/Change Control process from the start.

This role is stationed in Leiden and reports to the Manager QC Training and Compliance.

Key Responsibilities

  • Lead and author QC deviation, laboratory investigations, CAPAs and change control.
  • Work with QC SMEs to conduct root cause analysis.  Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.
  • Perform document revision, project, CAPA and deviation/ investigation, change management actions, related tasks and/ or continuous improvement efforts.
  • Train and mentor others on deviation, investigation, CAPA and change control process/ procedures.
  • May support health agency inspection as compliance (deviation, change control etc.) subject matter expert.
  • Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums)
  • Perform other tasks as required to support the QC laboratories


  • Bachelor’s degree in science, engineering, or related discipline.
  • 4+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute.
  • Knowledge of cell therapy analytical and microbiological testing preferred.
  • Demonstrated experience with Quality management systems.
  • Demonstrated technical writing skills.
  • Demonstrated experience in laboratory or biomanufacturing investigations and root cause analysis techniques preferred.

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

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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