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.
The BMS site of Boudry is a Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for Projects and New Product Introductions (NPIs), relying on flexible manufacturing and testing operations.
The Senior Specialist – QA Quality Operations is part of the Quality Operations team of BMS, Switzerland and acts as a Subject Matter Expert (SME) for the day-to-day Quality Operations activities, ensuring sustainable GMP compliance, operational robustness, inspection readiness and successful product delivery, both for routine commercial/clinical operations, for projects and NPIs. The role focuses on providing advanced expertise, supporting execution of Quality processes, and contributing to robust and compliant operations. The Senior Specialist partners with cross-functional teams and supports Quality strategies through hands-on involvement and expert input.
1. Quality Operations - Routine GMP Oversight
Provide expert support to Quality Operations activities for routine manufacturing activities.
Ensure sustained compliance with cGMP, BMS Global Quality processes and applicable regulatory requirements (FDA, EMA, Swissmedic).
Ensure appropriate quality oversight for deviation management, investigations, root cause analysis and CAPA implementation.
Assess and approve change controls for site-related projects and/or for product life-cycle projects with relevant quality SMEs.
Accountable for Quality deliverables, including Quality approval of documentation, Quality oversight of validation & qualification activities, deviations & CAPAs, and Change Control handling.
Participate and approve quality risk assessments.
Ensure continuous inspection readiness and represent Quality Operations during regulatory inspections and internal audits.
Populate, review, and approve creation/modification to master data in ERP/MES systems.
Perform batch record review of commercial bulk product batches manufactured using electronic MES platform or paper batch records.
Promote a strong Quality and GMP culture across operations through coaching and engagement.
2. Quality Operations – Projects, NPIs & CAPEX
Act as SME for Quality Operations within projects and NPIs.
Support and deploy project-specific, risk-based Quality strategies aligned with BMS standards.
Participate to the activities related to the quality oversight of the validation and C&Q activities within projects, i.e. during FAT/SAT and then IQ/OQ/PQ validation studies of equipment and processes, utilities and software/automation validations, as well as process validation, PAT methods and technology transfers
Represent Quality Operations in site and global project governance forums, if needed. Participate to the quality aspects’ coordination with internal/external stakeholders such as quality, development, AS&T, MS&T, PMO, manufacturing.
3. Continuous Improvement & Quality Transformation
Drive continuous improvement initiatives across Quality Operations
Promote risk-based thinking, Lean principles, simplification and digitalization.
Contribute to cost, cycle-time, robustness and sustainability improvements.
4. EHS & Compliance
Ensure compliance with EHS policies and applicable legal requirements.
Promote safe behaviors and act as a role model for BMS core behaviors.
5. Additional activities, if needed to support QA organization:
QC activities including but not limited to analytical transfer, investigation, specification, evaluation and the…