Senior Manager C&Q

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 main purpose of the C&Q senior manager is part of the site engineering and maintenance department. This role is responsible for managing processes related to qualification/validation activities.

Primary responsibilities include:

• Laboratory Equipment Qualification,
• Utilities and HVAC Qualification,
• Computerized System Validation.

He Develops and implements a strategic approach to ensure a validated and compliant state of operation for systems and equipment mentioned below. He Leads the validation execution and quality review of all validation documentation, ensuring external regulatory and internal guidelines and requirements are met.

All activities will have to be realized in the strict observance of the regulation cGMPs, FDA, of the hygiene environmental and safety rules.

Key Responsibilities:

• Lead the Validation/Qualification function for the BMS Boudry Manufacturing site and supporting Quality Control laboratories.
• Lead functions within the Validation/Qualification group responsible for installation, operational and performance qualification (IQ/OQ/PQ) of laboratory equipment, qualification of critical process utility systems and validation of computerized system.
• Oversee validation execution for all engineering projects (small to large). Establish Validation/Qualification project plans commensurate with the level of risk and manage the execution of qualification/validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality.
• Owns the Site Validation Master Plan for all related Validation/Qualification activities.
• Responsibilities include oversight of Validation/Qualification execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing requalification programs. This individual works in conjunction with Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies.
• Responsible for delivering Validation/Qualification projects under strict deadlines to ensure customer success and bulk drug supply. This includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports.
• Manage multiple projects while serving as a point of contact for Validation/Qualification execution projects.
• Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present Validation/Qualification philosophies and strategies to Health Authority inspectors and auditors.
• Works collaboratively with Manufacturing, Global Engineering, Site Engineering Quality control and Quality.
• Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiency.
• Ensure alignment with BMS directives and industry guidelines on Validation/Qualification.
• Develops and manages a high performance team responsible for Validation/Qualification execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and…