Senior Manager, QA Shopfloor Lead

Bristol Myers Squibb; Leiden; On-site; EUR 120,000 - 160,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Senior Manager, QA Operations to lead the QA Shopfloor program at the Leiden CTF. You will ensure GMP-compliant manufacturing, QA oversight, and timely resolution of issues across batch records and logbooks.

The role involves acting as deputy to the Associate Director, QA Shopfloor, driving continuous improvement, supporting inspections and regulatory audits, and coordinating cross-site quality initiatives within the network.

Responsibilities

• Act as deputy to the Associate Director, QA Shopfloor in leading the QA Shopfloor program at the Leiden CTF, and serve as back-up for day-to-day management of the QA Shopfloor team in the absence of the Associate Director, including prioritization of activities, and escalation of quality issues to QA management.
• Lead and drive continuous improvement initiatives within the QA Shopfloor program (e.g., procedures, batch record and logbook review process, ways of working, tools and digital systems) and ensure that improvements are implemented in a compliant manner through the applicable quality systems (e.g., change control).
• Represent QA Shopfloor (QASF representative) in larger site and cross-site (network) projects, such as new product introductions, facility, capacity expansions and process changes; ensure QA Shopfloor requirements, risks and resource impacts are identified, communicated and addressed.
• Contribute to the development and execution of the BMS Inspection Readiness plan at site QA level and lead inspection readiness activities within QA Shopfloor (e.g., self-inspections, shopfloor walk-throughs, mock inspections, documentation and data readiness). Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections and support the site inspection team (front room / back room).
• Help ensure that the QA Shopfloor team operates in compliance with applicable GMP regulations, BMS policies and procedures: monitor team compliance and performance indicators (e.g., timeliness of batch record review, deviation and CAPA timelines, training compliance, good documentation practices), identify trends and gaps, initiate and follow up on corrective actions, and report on these in site quality governance forums.
• Provide Quality Assurance oversight of GMP operations at the Leiden manufacturing site and provide direction and timely guidance to QA Shopfloor personnel during the handling and resolution of GMP events (deviations, non-conformances and corrective action assessments), including escalation of significant events.

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 Senior Manager, QA Operations is responsible for providing management for the QA Shopfloor program in accordance with Bristol-Myers Squibb (BMS) policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

Responsible for managing the activities of the shopfloor team to ensure Manufacturing, Warehouse and Quality Control 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.

This person is a key leader in the Quality Assurance management team and a champion for quality principles and compliance within the Quality organization.

Duties/Responsibilities:

• Act as deputy to the Associate Director, QA Shopfloor in leading the QA Shopfloor program at the Leiden CTF, and serve as back-up for the day-to-day management of the QA Shopfloor team in the absence of the Associate Director, including prioritization of activities, and escalation of quality issues to QA management.
• Lead and drive continuous improvement initiatives within the QA Shopfloor program (e.g., procedures, batch record and logbook review process, ways of working, tools and digital systems) and ensure that improvements are implemented in a compliant manner through the applicable quality systems (e.g., change control).
• Represent QA Shopfloor (QASF representative) in larger site and cross-site (network) projects, such as new product introductions, facility, capacity expansions and process changes; ensure QA Shopfloor requirements, risks and resource impacts are identified, communicated and addressed.
• Contribute to the development and execution of the BMS Inspection Readiness plan at site QA level and lead inspection readiness activities within QA Shopfloor (e.g., self-inspections, shopfloor walk-throughs, mock inspections, documentation and data readiness). Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections and support the site inspection team (front room / back room).
• Help ensure that the QA Shopfloor team operates in compliance with applicable GMP regulations, BMS policies and procedures: monitor team compliance and performance indicators (e.g., timeliness of batch record review, deviation and CAPA timelines, training compliance, good documentation practices), identify trends and gaps, initiate and follow up on corrective actions, and report on these in site quality governance forums.
• Provide Quality Assurance oversight of GMP operations at the Leiden manufacturing site and provide direction and timely guidance to QA Shopfloor personnel during the handling and resolution of GMP events (deviations, non-conformances and corrective action assessments), including escalation of significant events.
• Ensure timely Quality support to site compliance activities such as Change Control impact assessments, deviation impact assessments and the development of corresponding Corrective and Preventive Actions (CAPAs). Critically review investigations, interpret results and generate technical conclusions consistent with quality risk management principles.
• Develop and maintain a comprehensive understanding of the manufacturing processes followed for BMS products at the Leiden CTF an