Manager, QA Operations Investigations page is loaded Manager, QA Operations Investigations
Apply locations Leiden – NL time type Full time posted on Posted 2 Days Ago job requisition id R1568218

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

The Manager for Investigations for the Quality Assurance Operations organization at the Cell Therapy Facility (CTF) in Leiden, The Netherlands, is responsible for the quality review and approval of manufacturing and laboratory investigations at the CTF in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. The role will provide Quality oversight and assure the quality of manufactured products are in compliance with all applicalbe regulations and guidelines.

Functional responsibilities include review and approval of root cause analysis deviations and the resulting corrective/preventative actions from the deviations. This individual will also be responsible for maintenance and review of SOPs, and act as a Subject Matter Expert in quality investigations.

Key Responsibilities
• Participates in the startup of the CTF in Leiden, Netherlands including the development of Standard Operating Procedures and business processes supporting the site quality assurance program for deviations and CAPA.
• Reviews and approves investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, laboratory, facility, and utility systems.
• Authors technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
• Performs review and approval of site and department SOPs.
• Identifies and develops process improvement strategies and supports execution of site/team continuous improvement goals and projects.
• Identifies and reports any EHS, Quality, or Compliance concerns and takes immediate corrective action or escalation as required.

Experience:
• A minimum of 5 years' experience in biopharmaceutical operations.
• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent.
• Knowledge of cell therapy, analytical testing, or biotech bulk and finished product manufacturing is highly desirable.
• Knowledge of EU and US cGMP regulations and guidance.
• Knowledge and proven experience with IGJ, EMA, FDA, or other regulatory authority.

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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 scienceTM ", 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 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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