Senior Manager, Quality Systems - Change Control and Quality Risk Management Process Owner

Bristol Myers Squibb • Devens, MA

11d

About The Position

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 . Position Summary: The Senior Manager, Quality Systems - Change Control and Quality Risk Management (QRM) Process Owner is responsible for ownership and oversight of assigned quality systems per established local and global standards. This local process owner is accountable for the overall compliance and performance of the Change Control and QRM processes as they apply to the site level, including periodic assessments of process performance and continuous improvement opportunities.

Requirements

• Strong working knowledge of Tech Transfer, Computer System Validation, and Commissioning and Qualification processes
• Strong knowledge and proven experience in applying risk management tools and methods (e.g., FMEA, PHA, HAACP, Risk Ranking and Filtering)
• 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
• Ability to work in a fast-paced team environment and lead team and cross-functional stakeholders through changing priorities.
• Ability to think strategically, meet deadlines and prioritize work
• Ability to independently work across and influence cross-functional groups and network teams to ensure requirements are met
• Ability to motivate and foster a positive team environment
• Confident in making decisions, able to anticipate Quality issues and proactively solve problems
• Curious, with an ability to think critically to create innovative solutions
• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 8+ years of experience in a regulated industry, preferably with 4+ years of quality system experience including demonstrated experience with Change Control and Risk Management.
• Demonstrated proficiency with electronic system and database

Nice To Haves

• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Responsibilities

• Own and maintain the Devens Cell Therapy site Change Control systems, including the ownership and facilitation of site Change Control Review Board.
• Establish and drive Change Control governance maturity plans to improve site performance through data-based analysis and integration of management review through site Quality Council.
• Supports the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems, as well as applicable health authority regulations.
• Liaise with Technical Review Board, IT change management, and QA Technical Services teams to drive technical change management solutions.
• Lead complex problem solving to deliver compliance focused solutions through stakeholder management with local and global teams.
• Build & maintain strong relationships with partner functions.
• Site subject matter expert on relevant quality systems and ownership of site SOPs, Work Instructions, Training documents, and business process tools.
• Own and maintain the Devens Cell Therapy site QRM systems, including maintenance of the site Quality Risk Register.
• Establish and drive QRM governance maturity plans to improve site performance through data-based analysis and integration of management review through site Quality Council.
• Function as site Risk Champion and collaborate with stakeholders to develop appropriate actions to resolve quality system issues and drive risk reduction initiatives.
• Facilitate risk assessment activities as required.
• Promote the development of a risk-aware culture at BMS and ensure alignment of these efforts with broader Quality initiatives.
• Support front room External Inspection activities as site SME on relevant Quality System elements.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees