Senior Specialist, QA Operations Shopfloor

Bristol-Myers Squibb; Netherlands; On-site; EUR 70,000 - 95,000; Full time

Job summary

Bristol Myers Squibb Netherlands seeks a Sr. Specialist, QA Operations Shopfloor for the Cell Therapy Facility in Leiden, the Netherlands.

The role entails on-site, shift-based QA activities and real-time review of batch records to ensure cGMP compliance. The ideal candidate has a Bachelor's degree in engineering or life sciences, 4+ years of cGMP experience, and familiarity with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Qualifications

• Bachelor's degree in engineering or life/physical sciences preferred.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

• Perform QA shopfloor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shopfloor documentation.
• Ability to critically review investigations and generate technical conclusions consistent with Quality risk management principles.
• Demonstrate planning, organization, and relationship-building; support continuous improvement and CAPA processes.

Skills

Decision making

Relationship building

Analytical thinking

Problem solving

Planning & organizing

Self-directed

Team collaboration

Education

Bachelor's degree in engineering or science

High school diploma or associate degree accepted

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. 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 Sr. Specialist, QA Operations Shopfloor is responsible for quality activities at the Cell Therapy Facility (CTF) in Leiden, The Netherlands in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

NOTE: this is on-site and on shift role. No remote work available.

Duties/Responsibilities

• Perform QA shopfloor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shopfloor documentation.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision‑making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and Corrective and Preventive Actions (CAPAs) management.

Education/Experience/ Licenses/Certifications:

• 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.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred

Qualifications:

• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Must have sound knowledge and experience in regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Must possess an independent mindset. Work is self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in making decisio