Senior Manager C&Q

Bristol Myers Squibb seeks a Senior Manager of Compliance & Qualification for its Boudry manufacturing site. This leadership role oversees validation and qualification activities for laboratory equipment, utilities, HVAC systems, and computerized systems, ensuring regulatory compliance and operational integrity across the facility.

Responsibilities

• Lead validation/qualification function for BMS Boudry site and supporting QC laboratories
• Oversee installation, operational, and performance qualification of laboratory equipment and utility systems
• Manage validation execution for engineering projects while developing project plans aligned with risk level
• Own site validation master plan and oversee execution from change controls, capital projects, and requalification programs
• Develop and manage high-performance validation/qualification team with focus on recruitment, coaching, and continuous improvement

Requirements

• Bachelor's degree in engineering or related discipline with equivalent industry experience
• Minimum 5 years directly relevant validation/qualification experience in pharmaceutical manufacturing
• Proven managerial experience selecting, motivating, and retaining high-performing teams
• Experience presenting to Health Authority inspectors, external auditors, and corporate auditors
• Knowledge of distributed control systems, automation, and GAMP validation concepts
• Strong project management, technical writing, and communication skills
• Understanding of FDA, EMA, and other regulatory qualification/validation requirements