Manager AOP, QA Shop Floor

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

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 Summary

The Aseptic Observation Manager supports Cell Therapy manufacturing by providing expert oversight and feedback on aseptic techniques and cleanroom behaviors for operators verifiers and support personnel.

This role is central to sustaining the behaviors defined in the sites Contamination Control Strategy and reducing the potential for personneldriven contamination risks.

Working closely with Manufacturing Quality Assurance Training and Sterility Assurance the Manager elevates aseptic performance and reinforces a strong quality culture.

The role identifies behavior drift delivers realtime coaching and ensures observations are accurately documented and trended to drive meaningful addition the Manager contributes to deviation investigations change control evaluations GEMBA walks and broader sterility assurance activities. They also support the setup governance and continuous improvement of the Aseptic Observation Program to ensure consistent riskbased oversight across cleanroom operations.

Duties/Responsibilities:

Leadership & Program Governance

• Provide informal and indirect leadership for the Aseptic Observer team supporting the team lead with oversight planning scheduling and program development.
• Assist in setting up structuring and operationalizing the AOP including procedure creation qualification pathways observation tools and governance mechanisms.
• Ensure site-level alignment with global AOP standards Annex 1 expectations and CCS principles.
• Drive continuous improvement of the program through stakeholder feedback observations data and regulatory trends.

Aseptic Observations & Coaching

• Perform and support aseptic observations on the manufacturing floor to evaluate operator behaviors aseptic technique gowning and cleanroom conduct.
• Provide realtime coaching when appropriate and escalate issues following deviation and triage SOPs.
• Document observations with accuracy categorization and actionable comments for operators area managers and quality partners.

Sterility Assurance Activities

• Conduct routine GEMBA walks of manufacturing spaces to identify risks reinforce proper behaviors and detect early signs of contamination risks or facility concerns.
• Actively support investigations related to aseptic practices cleanroom behavior contamination events and procedural adherence.
• Participate in root cause analyses and contribute subjectmatter insights into aseptic technique and CCS gaps.
• Support evaluation of change controls by assessing impacts to aseptic operations personnel flow material flow cleanroom classification or behavior risk.
• Provide Sterility Assurance input to design procedural updates workflow optimization and operational readiness reviews.

Training Qualification & Cultural Reinforcement

• Contribute to creation and revision of aseptic training materials incorporating real-world examples from observation findings.
• Assist in preparing and delivering training sessions for operators supervisors and technical staff on aseptic behaviors contamination control principles and cleanroom expectations.
• Support training and qualification of new observers ensuring competency in technique assessment feedback delivery and documentation.

CrossFunctional Collaboration

• Partner closely with Manufacturing QA Operations EM Facilities and Training to ensure alignment of SOPs practices and CCS controls.
• Participate in crossfunctional forums to share trends propose process improvements and reinforce contamination control culture.
• Support planning and readiness for regulatory inspections by demonstrating AOP effectiveness documentation rigor and observationbased improvements.

Data Trending Metrics & Continuous Improvement

• Aggregate and analyze AOP data to identify recurring trends operator skill gaps and systemic issues impacting aseptic performance.
• Recommend targeted corrective actions and track the effectiveness of implemented improvements.
• Update leadership on key trends through monthly quarterly and annual reporting.
• Use observation insights to inform APQ requalification decisions behaviorbased coaching plans and updates to CCS or SOPs.

Qualifications:

Specific Knowledge Skills Abilities:

• Proven proficiency in coaching and providing feedback for front line operators is required.
• Extensive knowledge of SOPs and cGMPs and the knowhow to work and manage within a regulatory environment.
• Understanding of aseptic processing principles cleanroom behavior standards and contamination control strategies.
• Strong observational analytical and critical-thinking abilities.
• Adaptable to a fast-paced complex and ever-changing business environment.

Education/Experience/ Licenses/Certifications:

• Bachelors in relevant science or engineering discipline or equivalent in work experience.
• 5 years of experience in cGMP cell therapy manufacturing bioprocessing manufacturing or relevant experience.
• Experience in the following is highly preferred:
  • Cell therapy manufacturing observations training or management.
  • Aseptic processing in ISO 5/Grade A biosafety cabinets.

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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.

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

How We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

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