Manager, Quality Systems - Change Control and Quality Risk Management

Position Summary

The Manager Quality Systems - Change Control and Quality Risk Management (QRM) is responsible for supporting ownership and oversight of assigned quality systems per established local and global standards. This position supports 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.

Duties/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 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 problem solving initiatives 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.
• 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.

Reporting Relationship

This position is within the Devens Cell Therapy Compliance and Quality Systems Organization, reporting to the Associate Director of Quality Systems.

Qualifications

Specific Knowledge, Skills, Abilities:

• 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.
• Confidant in making decisions, able to anticipate Quality issues and proactively solve problems.
• Curious, with an ability to think critically to create innovative solutions.

Education/Experience/Licenses/Certifications:

• Bachelor's degree in STEM field preferred. High school diploma/associate’s degree with equivalent combination of education and work experience may be considered.
• 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.