Specialist, QA Operations Shopfloor

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 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. 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!

Position Summary

The Specialist, QA Operations Shopfloor oversees and partners with Manufacturing, Quality Control laboratories, and Warehouse Operations, to ensure compliance with Bristol Myers Squibb policies, standards, procedures, and Global current Good Manufacturing Practice (cGMP).

Key Responsibilities:

• Provide Quality on-the-floor oversight to Manufacturing, QC, Warehouse and Packout operations.

• Identify departures from approved procedures & responding to issues independently and escalating more complex issues to senior members.

• Independently assess discrepancies for entry into quality system and approve deviations, as applicable.

• Perform and document operational verification per approved procedures.

• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.

• Provide quality oversight to maintenance operations and support of pre-approved return to service plans.

• Perform area walkthroughs to identify quality issues, propose remediations and support implementation to ensure the floor and operations are in adherence with cGMP and approved procedures.

• Review manufacturing or testing records to ensure compliance with approved procedures.

• Communicate and resolve discrepancies independently and escalate as required.

• Author and review department owned documents.

• Maintain compliance with assigned learning plan.

• Support integration of newer team members.

• Support internal and external inspections as required.

• Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.

• Build relationships with specialized function

Key Competencies

• Ability to understand, follow and apply approved procedures.

• Proficient computer skills with knowledge of MS Office.

• Ability to understand problems and propose practical solutions.

• Ability to communicate effectively with cross functional peers andvarious levels of cross functional management through written and verbal skills.

• Ability to work in a fast-paced team environment with changing priorities.

• Detail oriented and task focused with ability to meet deadlines and prioritize assigned work.

• Active listening skills and ability to understand varied perspectives.

• Ability to independently make decisions and recognize the need for escalation of issues.

• Ability to seek out opportunities for improvement.

Qualifications & Experience

• Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred. High school diploma/ Associate’s degree with equivalent combination of education and work experience is acceptable.

• 0-2 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

• Experience with quality management systems preferred.

• Experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP) preferred.

#LI-Onsite

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.

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

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 to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

Data Protection

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

R1602744 : Specialist, QA Operations Shopfloor