Senior Manager C&Q - Validation & Qualification

About the role

Bristol Myers Squibb is hiring a Senior Manager C&Q for its Boudry manufacturing site, within the site engineering and maintenance department. The role manages qualification and validation activities for laboratory equipment, utilities and HVAC, computerized systems and manufacturing control systems, and oversees the site's validation master plan.

Key responsibilities

• Lead the validation/qualification function for the Boudry site and its supporting quality control laboratories, covering IQ/OQ/PQ of laboratory equipment, critical utility systems and computerized systems.
• Oversee validation execution for all engineering projects, from small to large, and own the site validation master plan.
• Manage validation projects arising from change controls, capital projects, shutdowns and requalification, working with Quality Assurance on plans and strategies.
• Deliver projects on strict deadlines, producing plans, protocols, test scripts, risk assessments and summary reports.
• Act as validation subject matter expert for health authority and auditor inspections, and provide inspection readiness training to junior staff.
• Manage a high-performance team, including recruitment, development, coaching and mentoring, and lead continuous improvement.
• Ensure regulatory and GxP compliance and align with BMS directives and industry guidelines.

Required profile

• Degree in engineering or a related field, with minimum 5 years of direct experience in validation/qualification (equipment, HVAC and utilities, computer systems, manufacturing control systems and laboratory instrumentation).
• Previous managerial experience preferred, including team selection, motivation and retention, and resource and financial planning.
• Experience presenting validation strategies to health authorities, external and internal auditors.
• Proven ability to work in a matrix environment and lead cross-functional teams.

Required skills

• Knowledge of engineering documentation (P and IDs, process flow diagrams, SOPs) and regulatory requirements (FDA, EMA, ICH Q7, Q8, Q9).
• Familiarity with distributed control systems and GAMP validation concepts; lean principles preferred.
• Strong project management, communication and technical writing skills.
• Knowledge of critical utility systems (compressed gas, vacuum, waste) and facility management systems such as CMMS.