Senior Manager, Compliance Cell Therapy

Bristol Myers Squibb is seeking a Senior Manager, Compliance, at the Cell Therapy Facility (CTF) in Devens, MA.  This individual will be the lead a high performing team and acts as Local Process Owner responsible for the Self-Inspection Program, Pre-Licensure Inspection Readiness, Audits and HA Inspections and Regulatory Surveillance. This role will be interacting and supporting CTDO functions at our Devens, MA locations from a Compliance perspective. Specifically, partnering with different functions (i.e. Operations, Supply Chain, MS&T) to proactively identify compliance risks, develop collaborative solutions,  and track effective resolution of actions to close compliance gaps.

The Senior Manager reports to the Director, Compliance and Quality System, Cell Therapy.

Job Responsibilities

• Local process owner for Audits & Inspections at Devens Cell Therapy Facility with responsibility to ensure site alignment with global policies and procedures.
• Key point of contact with CTDO Regulatory functions to respond to pre- and post-filing requests for site based information, includes extensive communication and coordination to fill a variety of requests.
• Responsible for the Cell Therapy Facility Self-Inspection Program. May conduct audits of Cell Function functions relative to BMS policies and procedures as well as the relevant HA requirements.
• Provides compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements; supporting local projects as the Compliance & Quality Systems representative as needed (researching as needed on complex compliance issues).
• Manage and develop direct reports by facilitating on-going performance management activities. Lead team members, foster professional development and growth, and promote teamwork and cross-functional collaboration.
• Participates as a core team member in any corporate or health authority inspections and leads cross functional teams to develop responses, tracking the commitments to completion.
• Leads site inspection readiness efforts with regard to preparing site for health authority inspections and corporate audits.
• Leads Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments and proactive action plans
• Develop and manage the Inspection Readiness annual plan, including identification of anticipated inspections
• Represents site as the Quality representative on network compliance initiatives and providing compliance leadership, guidance and problem solving skills.
• Participates in site Quality Council and provides metrics reporting as needed.