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 RESONSIBILITIES
- 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
KNOWLEDGE AND SKILL
- 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
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:Devens - MA - US: $114,100 - $138,267
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 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.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include 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.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
