About this role
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. 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.