Manager Quality Systems, Change Control and Quality Risk Management

Bristol-Myers Squibb - Devens, MA

Full-time - Mid Level

Devens, MA

Chemical Manufacturing

About the position

The Manager Quality Systems - Change Control and Quality Risk Management (QRM) at Bristol-Myers Squibb is responsible for overseeing quality systems in compliance with local and global standards. This role focuses on the Change Control and QRM processes at the Devens Cell Therapy site, ensuring performance assessments and continuous improvement. The position involves collaboration with various teams to drive compliance and risk management initiatives, ultimately contributing to the quality and safety of biopharmaceutical products.

Responsibilities

• Support oversight of the Devens Cell Therapy site Change Control system, including facilitation of site Change Control Review Board.
• Drive Change Control governance maturity plans to improve site performance through data-based analysis and integration of management review through site Quality Council.
• Support the administration and maintenance of the site change control system, assuring consistency with established 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 problem-solving initiatives to deliver compliance-focused solutions through stakeholder management with local and global teams.
• Build & maintain strong relationships with partner functions.
• Act as the site subject matter expert on relevant quality systems and ownership of site SOPs, Work Instructions, Training documents, and business process tools.
• Support oversight of the Devens Cell Therapy site QRM systems, including maintenance of the site Quality Risk Register.
• Drive QRM governance maturity plans to improve site performance through data-based analysis and integration of management review through site Quality Council.
• Function in a site Risk Champion role when required 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 Internal and External Inspection activities as site SME on relevant Quality System elements.

Requirements

• Bachelor's degree in STEM field preferred.
• 6+ years of experience in a regulated industry, preferably with 2+ years of quality system experience including demonstrated experience with Change Control and Risk Management.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated proficiency with electronic systems and databases.
• Working knowledge of Tech Transfer, Computer System Validation, and Commissioning and Qualification processes.
• Working knowledge of 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.
• 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 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.

Benefits

• Competitive salary
• Comprehensive health benefits
• Flexible work environment
• Opportunities for professional development
• Diversity and inclusion programs