Senior QA Shopfloor Lead — GMP & Compliance Champion

Bristol Myers Squibb; Leiden; Presencial; EUR 120.000 - 160.000; Jornada completa

Descripción de la vacante

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.

Responsabilidades

• 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.

Descripción del empleo

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.