Senior Specialist, QA Operations Shopfloor

Bristol Myers Squibb; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb Netherlands seeks a Sr. Specialist, QA Operations Shopfloor to manage quality activities at the Cell Therapy Facility in Leiden, Netherlands, ensuring cGMP compliance and real-time batch record reviews.

This on-site, shift role requires strong investigative writing and cross-functional collaboration. Qualifications include a Bachelor’s degree in engineering or life sciences and 4+ years of cGMP experience, with preference for cell therapy/manufacturing exposure.

Qualifications

• Bachelor's degree in engineering, life or physical sciences preferred (biology/biochemistry/chemistry).
• 4+ years of relevant cGMP experience, preferably with 1+ year in manufacturing site.

Responsibilities

• Perform QA shopfloor activities.
• Ensure manufacturing compliance with procedures and batch records.
• Real-time review of manufacturing batch records.
• Review manufacturing shopfloor documentation.
• Authorship and critical review of investigations and conclusions.
• Plan, organize, and build cross-functional relationships.
• Knowledge of quality processes including CAPAs, deviations, and change control.

Skills

Decision-making

Relationship building

Problem solving

Analytical thinking

Planning and organizing

Continuous improvement

Quality systems

cGMP knowledge

Education

Bachelor's degree in engineering or life science

High school diploma/Associate’s with relevant experience

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 decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of global cGMP requirement

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.

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 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.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602743 Senior Specialist, QA Operations Shopfloor