Senior Specialist, QA Operations

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 planning of the project-related testing activities in alignment with the testing planning/capacity.
• Participate to complaints processes
• Supplier/Raw material quality related activities

Knowledge, skills & abilities

• Good knowledge of cGMPs and global regulatory requirements (FDA, EMA, Swissmedic).
• Knowledge of all phases from the global drug development process and clinical trial data flow up to analytical/technology transfer to manufacturing/testing site and product launches.
• Good experience in routine QA Operations combined with proven participation to projects or NPIs.
• Effective organizational skills.
• Fluency in French and English.
• Experience in Operational Excellence and digital initiatives is a strong plus.
• Good knowledge of Oral Solid Dosage (OSD) manufacturing and testing processes is preferred.

Education, experience, licenses & certifications

• Minimum 5 years of experience in Quality Assurance / Quality Operations in a pharmaceutical or biotechnological manufacturing environment.
• Good management, negotiation and decision skills.
• At ease to work in a matrix environment.
• Proactive, strong ability to adapt rapidly to changes.
• Good written & oral communication skills, internally within the function and externally with cross-functional teams, at site and global level.
• Work independently on routine tasks, make proposals and facilitate decision when escalation is needed.

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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.

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R1608057 : Senior Specialist, QA Operations