Manager, GMP Cleaning Program and Projects Lead
Bristol Myers Squibb
August 20, 2026
Remote friendly (Devens, MA)
United States
Operations
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.
Major Duties and 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; drive 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).
- Integrate GMP cleaning requirements with facility design, construction, and maintenance activities.
- Own vendor performance (qualified personnel, KPI/SLA compliance, audit-ready execution).
- Maintain inspection readiness via proactive risk identification/mitigation and lead audit preparation/SME support.
- Participate in cross-training within the department.
- Ensure GDP/ALCOA+ compliant documentation aligned across Maximo, Quality systems, and operational records.
- Drive continuous improvement via KPI trending, audit insights, and process optimization.
Knowledge and Skill / Qualifications:
- Bachelor’s degree in Engineering, Science, or related field (or equivalent experience).
- 2–5+ years’ experience in GMP manufacturing, facilities, or Quality Compliance environments.
- Experience in GMP cleaning and data integrity (GDP/ALCOA+) with regulatory expectations.
- Ability to manage multiple complex programs/projects simultaneously.
- Strong understanding of GMP facilities operations/infrastructure.
- Knowledge of EHS/OSHA requirements and safety program integration.
- Effective leadership, communication, and cross-functional collaboration.
- Ability to operate independently in a fast-paced, highly regulated environment.
Compensation:
- Devens, MA (US): $114,100 - $138,267.
Benefits (explicitly stated):
- Health Coverage (medical, pharmacy, dental, vision); Wellbeing Support; Financial Well-being and Protection (401(k), disability, life insurance, etc.); Paid Time Off (details by role/location).
Application instructions:
- Not specified in the provided text.
- 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.
Major Duties and 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; drive 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).
- Integrate GMP cleaning requirements with facility design, construction, and maintenance activities.
- Own vendor performance (qualified personnel, KPI/SLA compliance, audit-ready execution).
- Maintain inspection readiness via proactive risk identification/mitigation and lead audit preparation/SME support.
- Participate in cross-training within the department.
- Ensure GDP/ALCOA+ compliant documentation aligned across Maximo, Quality systems, and operational records.
- Drive continuous improvement via KPI trending, audit insights, and process optimization.
Knowledge and Skill / Qualifications:
- Bachelor’s degree in Engineering, Science, or related field (or equivalent experience).
- 2–5+ years’ experience in GMP manufacturing, facilities, or Quality Compliance environments.
- Experience in GMP cleaning and data integrity (GDP/ALCOA+) with regulatory expectations.
- Ability to manage multiple complex programs/projects simultaneously.
- Strong understanding of GMP facilities operations/infrastructure.
- Knowledge of EHS/OSHA requirements and safety program integration.
- Effective leadership, communication, and cross-functional collaboration.
- Ability to operate independently in a fast-paced, highly regulated environment.
Compensation:
- Devens, MA (US): $114,100 - $138,267.
Benefits (explicitly stated):
- Health Coverage (medical, pharmacy, dental, vision); Wellbeing Support; Financial Well-being and Protection (401(k), disability, life insurance, etc.); Paid Time Off (details by role/location).
Application instructions:
- Not specified in the provided text.