Senior Manager, QA Shopfloor Lead

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.

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 and of the associated risk management control strategy, in order to identify process risks and the critical controls around the associated processing steps.
• Collaborate with stakeholders across the site (e.g., Manufacturing, MSAT, Quality Control, Warehouse, QA Disposition, Validation, Engineering and Facilities) and with QA counterparts across the BMS Cell Therapy network; effectively communicate status, risks and escalations to QA management.
• Support the onboarding, training and qualification of QA Shopfloor personnel; coach and mentor team members and enable their individual growth; support the Associate Director in people processes (e.g., hiring, performance and development discussions) as delegated.
• Support the development of departmental goals, objectives and key performance indicators and ensure the timely completion of QA Shopfloor deliverables, including real-time review of manufacturing batch record documentation and logbooks.
• Collaborate with other leaders across the organization and contribute to the continuous improvement and lifecycle management of implemented GMP policies and the quality management system.
• Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture and values.
• The Senior Manager, QA Shopfloor Lead reports into the Associate Director, QA Shopfloor. The position ha s no direct report s; the Senior Manager, QA Shopfloor Lead acts as delegate for the Associate Director in the management of the QA Shopfloor team during absence.

Requirements

• Specific Knowledge, Skills, Abilities:
• Demonstrated experience building and leading exceptional teams is required.
• Demonstrated excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
• Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values.
• 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.
• 8+ years of relevant cGMP experience, preferably with 4+ year of supervisory experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required. Project management experience is preferred.
• Demonstrated experience with quality management systems.
• Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP), and electronic quality management systems (eQMS).
• LI-Onsite
• Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.
• 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 doesn’t perfectly match your resume, we encourage you to apply anyway.

Conditions

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 https://careers.bms.com/ways-of-working.

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 adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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 this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607893 : Senior Manager, QA Shopfloor Lead