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Associate Director, QA Engineering

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

Job Summary

Bristol Myers Squibb is seeking an Associate Director, QA Engineering at the Cell Therapy Facility (CTF) in Leiden, The Netherlands. The QA Engineering (QE) team is responsible for providing quality leadership, oversight and governance primarily to technical elements topics in the manufacturing facility.  The Associate Director, QA Engineering is responsible for leading the team, establishing processes and ways of working, and providing guidance to members of the QE team. In this role, senior-level expertise and judgement is provided to other functions related to activities the QE team is representing quality for. This position reports to the head of Quality Assurance Operations, Leiden Cell Therapy Manufacturing Facility.

Job Responsibilities

  • Sets and executes strategy and manages daily activities of the QA Engineering team located at the Leiden Cell Therapy Manufacturing Facility. Assures individual and team objectives are met in a timely manner.
  • Lead and champion proactive identification and resolution of technical and compliance issues/gaps.
  • Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers/new product introductions supporting the Qualification and Validation teams.
  • Provide QA oversight to all Technical Transfers (processes and methods), Aseptic Process Validations, Process Performance Qualifications and Comparability Studies, as well as QA support to process and analytical changes and other engineering activities, to ensure successful execution and documentation.
  • Provide leadership from QA as the intended source for QA leadership and support to Qualification and Validation lifecycle activities related to facility, instruments, equipment, processes and methods.  Provides QA leadership and oversight of validation plans, qualification protocols, and associated reports and procedures where applicable, as well as calibration/maintenance programs.
  • Review and approve complex and/or technically-oriented documentation in support of GMP operations including but not limited to facility plans, commissioning/qualification/validation and other technical protocols and reports, standard operating procedures, CAPAs, deviations, etc.
  • Provides appropriate support through the QA Engineering team to technical investigations requiring complex root cause analysis and resolution efforts (i.e., CAPAs)
  • Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)
  • Collaborate with stakeholders within and outside of the Leiden Cell Therapy Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
  • Contribute to the development and execution of the facility’s site-clearance inspection and commercialization readiness plan
  • Act as Quality Engineering Subject Matter Expert during regulatory inspection

Qualifications and Education Requirements

  • Bachelor of Science degree required. Minimum 12 years relevant work experience and minimum 5 years of leadership experience. Equivalent combination of education and experience acceptable.
  • Strong leader that has developed high performing, independent and capable teams of experienced professional employees.  Experience with coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation required. Minimum of 5 years of people management.
  • Previous working experience in a Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization
    Knowledge of cGMP regulations, automation standards from relevant health authorities including all guidelines applicable to biologics and cell therapy, as well as ATMP Regulations.
  • Familiar with automation requirements/guidance. Detail oriented, with strong GMP, Quality and Engineering experience.
  • Knowledge of and familiarity with Cell Therapy QC methods and method transfer is required.
  • Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
  • Must be skilled in planning, organizing, and project management concepts.
  • Proven capability for leading cross-functional project teams and drives team performance and results. Contributes to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.
  • Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes.
  • Capable of recognizing and resolving Quality issues, particularly of a technical nature; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
  • Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
  • Possesses capability for effectively managing internal and cross-functional conflicts and disagreements, but able to stand alone on issues.



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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