Senior GMP Cleaning & Projects Leader

Bristol-Myers Squibb; Massachusetts; On-site; USD 114,100 - 138,267; Full time

Benefits offered by this job

On-site work at Devens

Competitive benefits

Flexible work arrangements

Job summary

Bristol Myers Squibb seeks a Manager to lead the GMP Cleaning program and related campus projects at the Devens, MA site. You will own cleaning, disinfection, data integrity, and regulatory responses, driving compliant investigations and sustainable corrective actions.

You will oversee Quality Events, CAPAs, and change controls while coordinating with facilities, QA, and EHS to ensure inspection readiness and on-time project delivery.

Qualifications

• 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.

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 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.

Skills

GMP Cleaning

Regulatory Compliance

Data Integrity

CAPA & Deviations

Audit Readiness

Project Management

Cross-Functional Leadership

GMP Knowledge

Education

Bachelor’s degree in Engineering/Science

Tools

Maximo

Quality Systems

Job description

Bristol Myers Squibb seeks a Manager to lead the GMP Cleaning program and related campus projects at the Devens, MA site. You will own cleaning, disinfection, data integrity, and regulatory responses, driving compliant investigations and sustainable corrective actions.

You will oversee Quality Events, CAPAs, and change controls while coordinating with facilities, QA, and EHS to ensure inspection readiness and on-time project delivery.