Senior Manager, QA Shopfloor Lead

• 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.

• 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.

• 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).

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