**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 rich in diversity. 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: careers.bms.com/working-with-us . **Position:** Compliance and Quality Systems **Location** : Devens, MA. **Key Responsibilities:** + Supports the site as Subject Matter Expert (SME) in compliance and regulations, internal audit (Self-Inspection), Annual Product Quality Review, Global Regulatory Observation Evaluations (GROe), Commercial and Clinical Change Management. + Supports the Devens Self-Inspection program as a lead auditor. Develops, plans and conducts audits, writes audit reports, reviews and tracks corrective actions and audit closures. + Authors Annual Product Quality Reviews, including project management, completion of report sections by applicable Subject Matter Experts (SME), and review/approval by established timelines. Provides training to authors and SMEs . + Provides quality review, approval, and impact assessments on change control records. Assures consistent, effective use of the change control system for all site change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements. Facilitates the Devens Local Change Review Board (LCRB), including preparation of the meeting agenda and minutes. + Reviews and assesses network regulatory observations (GROe) with site SMEs against site processes and procedures. Ensures a robust response is provided and all commitments are tracked for timely completion. + Supports the site Inspection Readiness Program by conducting prep sessions with SMEs and user training on audits as needed. + Core inspection team member. Supports SME preparation, back room and/or front room during inspections. Executes targeted inspection preparation activities. Generates Quality System queries and reports as needed during inspections. + Maintains applicable site procedures and drives opportunities for continuous improvement in support of enhanced quality system performance. Reviews and assesses more complex policy/procedure revisions, network regulatory observations, and compendia updates against site processes and procedures. Leads remediation plans for major impact or complex observations. Ensures all commitments are tracked for timely completion. + Manages program metrics process by developing applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs. Develops appropriate action plans as needed to remediate or continually improve on quality system performance. Presents related metrics to site Quality Council and operations management. **Qualifications & Experience:** + Knowledge of science or engineering generally attained through studies resulting in a Bachelor's degree in a scientific or technical discipline. + A minimum of 8 or more years of relevant experience in a biologics or pharmaceutical manufacturing environment is required. Prior GMP Compliance / Quality Systems experience is preferred. + Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required. + Basic understanding of manufacturing processes, drawings and specifications and quality systems, including knowledge of applicable U.S. and E.U. cGMP regulations/guidance pertaining to change control. + Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, with demonstrated knowledge of subject matter related to quality and compliance. + Previous work experience with TrackWise/Veeva and responsibilities related to metrics and data analysis preferred. + Candidate must be familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMA, Health Canada, etc. + Excellent computer skills and proficiency with MS Office is required. Advanced knowledge of Excel preferred. 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. **\#LI-Onsite** **BMSBL** 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. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1588924 **Updated:** 2025-01-26 01:44:36.955 UTC **Location:** Devens-MA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.