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