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Manager, GMP Cleaning Program and Projects Lead Devens - MA - US R1604660 Posted a day ago
Job in
Fall River, Bristol County, Massachusetts, 02720, USA
Listed on 2026-08-03
Listing for:
Bristol-Myers Squibb
Full Time
position Listed on 2026-08-03
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:
** 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…
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