Manager, GMP Cleaning Program and Projects Lead

Bristol Myers Squibb • Devens, MA

4d • Onsite

About The Position

PRINCIPAL OBJECTIVE OF THE POSITION: Ensure safe, compliant, and inspection-ready GMP facility operations through end-to-end ownership of GMP Cleaning programs, Quality and Safety Event management, regulatory response execution, and delivery of facility-driven projects. Drive sustained compliance by integrating operational execution, data integrity, continuous improvement, and risk management across all GMP cleaning, infrastructure, and supporting systems.

Requirements

• Bachelor’s degree in Engineering, Science, or related field (or equivalent experience)
• 2–5+ years of experience in GMP manufacturing, facilities, or Quality Compliance environments
• Experience in GMP cleaning, data integrity (GDP / ALCOA+), and regulatory expectations
• Demonstrated ability to manage multiple complex programs and projects simultaneously
• Strong understanding of facilities operations and infrastructure within GMP environments
• Knowledge of EHS/OSHA requirements and safety program integration
• Effective leadership, communication, and cross-functional collaboration skills
• Ability to operate independently in a fast-paced, highly regulated environment

Responsibilities

• Own end-to-end GMP Cleaning program (cleaning, disinfection, data integrity) ensuring SOP compliance and continuous inspection readiness
• Serve as owner of Quality Events (deviations, CAPAs, change controls) and Safety Events, driving timely, inspection-defensible investigations and sustainable corrective actions
• Lead and author regulatory responses (FDA/internal audits) and proactively identify trends to prevent recurrence
• Deliver campus projects (scope, schedule, compliance, change control/validation as applicable)
• Ensure integration of GMP cleaning requirements with facility design, construction, and maintenance activities
• Own vendor performance, ensuring qualified personnel, KPI/SLA compliance, and audit-ready execution with a trust but verify mindset
• Maintain inspection readiness through proactive risk identification and mitigation (compliance gaps, data integrity risks) and lead audit preparation/SME support
• Participate in cross-training activities within department organization.
• Ensure GDP/ALCOA+ compliant documentation and alignment across Maximo, Quality systems, and operational records
• Drive continuous improvement through KPI trending, audit insights, and process optimization

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager