Senior Manager, Quality Systems, Investigations and CAPA Process Owner in Devens, MA

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: careers.bms.com/working-with-us.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Manager, Quality Systems, Investigations and CAPA Process Owner is responsible for ownership and oversight of the Investigations and CAPA quality systems, per established local and global standards. This local process owner is accountable for the overall compliance and performance of the Investigations and CAPA processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities.

Shifts Available:

TBD

Responsibilities:

• Review and approve complex site investigations and CAPA associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Ensure Investigations and associated notifications to management (NTM) and CAPA are robust and adequately address requirements and risks
• Own and maintain the site Investigations and CAPA systems, including: 
  • Assuring local compliance with applicable BMS Policies, Guidelines, and Directives and ensures consistency with site and global procedures and/or specifications. 
  • Leading the Investigation and CAPA Review Boards
  • Identifying appropriate measures for quality system health and collecting, analyzing, and communicating data to stakeholders
  • Utilizing data to identify areas for improvement and driving improvement initiatives related to investigations and CAPA
  • Setting clear quality expectations for the quality system and providing the tools, training, and support required for users to succeed
  • Serving as site champion and representative for global investigations, CAPA, NTM, and complaints initiatives, engaging appropriate stakeholders, as applicable
• Identify improvement opportunities and drive execution of site continuous improvement goals and projects related to investigations and CAPA
• Influence effective and efficient quality system programs throughout the site
• Act as subject matter expert and present program overview and related topics during audits.
• Maintain compliance with assigned learning plan.
• Act as Subject Matter Expert of for investigations, CAPA, and NTM programs and provide guidance/ coaching to users
• Lead meetings and represent function at cross functional and network meetings.
• Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.

Knowledge, Skills, Abilities:

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines
• Proficient computer skills, with knowledge of digital tools such as MS Office, and ability to learn and work with new software applications
• Advanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed actions
• Ability to critically review reports, interpret results, and assess and challenge technical conclusions consistent with Quality Risk Management principles
• Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy
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