Senior Specialist, QA Operations

About the role

Bristol Myers Squibb's Boudry site manufactures oral solid dosage drugs and is a center of excellence for projects and new product introductions (NPIs). The Senior Specialist, QA Operations is part of the Quality Operations team and acts as a subject matter expert for day-to-day Quality Operations, ensuring sustainable GMP compliance, inspection readiness and successful product delivery for routine commercial and clinical operations, projects and NPIs.

Key responsibilities

• Routine GMP oversight: support daily manufacturing quality, ensure compliance with cGMP, BMS global quality processes and FDA, EMA and Swissmedic requirements, and oversee deviations, investigations, root cause analysis and CAPA implementation
• Approve change controls, quality risk assessments and master data in ERP/MES systems, and review batch records for commercial bulk products
• Ensure inspection readiness and represent Quality Operations during regulatory inspections and internal audits
• Quality oversight of validation and qualification activities, including FAT/SAT, IQ/OQ/PQ, process validation, PAT methods and technology transfers, and participate in project governance forums
• Drive continuous improvement, risk-based thinking, Lean principles and digitalization, and promote EHS compliance and safe behaviors
• Additional work as needed: QC activities, complaints handling and supplier/raw material quality

Required profile

• Minimum 5 years of experience in Quality Assurance / Quality Operations in a pharmaceutical or biotechnological manufacturing environment
• Good knowledge of cGMP and global regulatory requirements (FDA, EMA, Swissmedic)
• Experience in routine QA operations combined with proven participation in projects or NPIs
• Fluency in French and English
• Good written and oral communication, able to work independently and in a matrix environment

Required skills

• Knowledge of the drug development process and clinical trial data flow up to manufacturing and launch
• Good knowledge of oral solid dosage manufacturing and testing processes preferred
• Experience in operational excellence and digital initiatives is a strong plus