Manager, QC Systems and Support

Bristol-Myers Squibb; Leiden; On-site; EUR 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb Netherlands seeks a Manager QC Systems and Support to lead the QC Systems and Support team, ensuring safety, quality, and performance targets are met. You will author and approve records, manage CAPAs, and drive continuous improvement across QC processes.

You will mentor staff, coordinate cross-functional activities, and prepare the area for internal and external inspections in a high-paced, regulated environment at Leiden Bio Science Park.

Qualifications

• Bachelor's degree in science or equivalent; advanced degree preferred.
• 6–8+ years in a regulated laboratory setting.
• 2+ years of leadership experience required.
• Experience with sample management and incoming goods control.
• Knowledge of quality management systems.
• Knowledge of data integrity principles.
• Familiar with computerized systems and regulatory guidelines.

Responsibilities

• Provide direct management of the QC Systems and Support team and oversee daily activities.
• Develop and execute a work plan for the team, ensuring safety, quality, and performance targets.
• Author, review and approve records and technical documents ensuring results comply with requirements.
• Own and evaluate change controls, investigations, deviations and CAPAs.
• Hire, coach, mentor and develop team members; resolve conflicts.
• Lead team meetings and cross-functional operational meetings; act as advisor.
• Ensure staff are trained and qualified for assigned tasks.
• Identify and mitigate risks impacting lab operations, safety, and compliance.
• Lead QC systems design, implementation and continuous improvement.
• Troubleshoot non-routine and complex issues using scientific principles.
• Support inspections and ensure readiness of the responsible area.

Skills

Regulatory compliance

cGMP knowledge

Leadership

Project coordination

Lean/Six Sigma

Data integrity concepts

Problem solving

Communication

Education

Bachelor's degree in science

Advanced degree preferred

2+ years leadership experience

Tools

Quality management software

Job description

At Bristol Myers Squibb, our employees often ask, \"Who are you working for?\"-a 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 bms.com/nl or careers.bms.com/nl

Position Summary

The Manager QC Systems and Support provides direct management to Technicians, Associates and Specialists, as applicable, of the QC Systems and Support team and oversees the daily activities. Develop and execute a work plan for the team, ensuring safety, quality, and performance targets are achieved. Track, trend, and report key performance metrics.

Duties/ Responsibilities

• Provide direct management of the QC Systems and Support team and oversee the daily activities.
• Develop and execute a work plan for the team, ensuring safety, quality, and performance targets are achieved. Track, trend, and report key performance metrics.
• Author, review and approve records and technical documents ensuring results are compliant with requirements, corporate guidelines and regulations.
• Own and evaluate relevant change controls, investigations, deviations and CAPAs.
• Hire, coach, mentor and develop team members to support the business operations and employee career development. Resolve personnel conflicts in the workspace.
• Lead team meetings and cross functional operational meetings. Act as a point of contact and technical advisor for all work in the assigned area.
• Communicate effectively including escalations and cascades of critical information to ensure effective business operations.
• Provide performance evaluations and support development of direct reports (team members)
• Ensure employees are properly trained and qualified to perform assigned tasks.
• Identify and mitigate risks that could negatively impact the lab operations, safety, compliance.
• Lead team resources in the design, implementation and continuous improvement of Quality Control systems.
• Apply technical knowledge & scientific principles to perform troubleshooting and problem solving for non-routine & complex issues.
• Ensure responsible area and/ or process is in state of inspection readiness at all times. Support internal and external inspections.
• Perform other tasks as required to support the QC laboratories

Qualifications:

Specific Knowledge, Skills, Abilities

• Ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements.
• Strong leadership, coordination and communication skills.
• Ability to work collaboratively in a high-paced team environment, meet deadlines and prioritize work from multiple activities.
• Advanced problem-solving ability/ mentality, technically adept, logical and detail oriented.
• Strong mentoring/ coaching, influencing, negotiating and personnel interaction skills.
• Ability to apply Lean, Six Sigma and Risk Management concepts and tools preferred.

Education/Experience/ Licenses/Certifications

• Bachelor's degree or equivalent required, preferably in science.
• Advanced Degree preferred.6-8+ years of relevant laboratory work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute 2+ years of experience within a regulated environment.
• 2+ years of leadership experience required.
• Demonstrated experience with various processes & techniques such as sample management, incoming goods control, laboratory experience.
• Working knowledge of quality management systems
• Working knowledge and implementation of data integrity principles.
• Advanced knowledge of computerized systems and enter