Senior Specialist, QA Operations

Bristol Myers Squibb; Boudry; On-site; CHF 140,000 - 180,000; Full time

Job summary

Bristol Myers Squibb’s Boudry site in Switzerland seeks a Senior Specialist, QA Quality Operations to ensure sustainable GMP compliance, robust operations, and inspection readiness. You will act as SME for day-to-day Quality Operations, support NPIs and CAPEX, and drive continuous improvement.

This role partners with cross-functional teams across the site and global projects. The role focuses on advanced quality expertise, executing Quality processes, and coaching others to promote a strong

Qualifications

• Minimum 5 years of experience in Quality Assurance / Quality Operations in pharma manufacturing.
• Good management, negotiation and decision skills.
• Comfortable working in a matrix environment.
• Proactive, adaptable to changes.
• Excellent written and spoken communication with cross-functional teams.
• Work independently on routine tasks and drive proposals when escalation is needed.

Responsibilities

• Provide expert oversight of routine QA Operations and GMP compliance.
• Lead quality risk assessments and CAPA processes.
• Review batch records and ensure quality approvals for documentation.
• Support validation, qualification, and PQ/IQ/OQ testing activities in projects.
• Participate in project governance and cross-functional quality coordination.

Skills

French & English

cGMP knowledge

QA Operations experience

Tools

ERP/MES systems

Job 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.

The BMS site ofBoudryis 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, inspectionreadinessand 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 causeanalysisand 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 continuousinspectionreadiness 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,simplificationand digitalization.
• Contribute to cost, cycle-time,robustnessand 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 ofcGMPsand 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.

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.

How We Work

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustment prior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. 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/

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R1608057 : Senior Specialist, QA Operations