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.
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.
Qualifications and Education Requirements
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
A minimum of 8 years of relevant experience including 4 years of GMP Quality experience.
Proven experience in Health Authority inspection preparation and management (backroom and front room) is required.
Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc. Experience with Cell Therapy specific regulations highly desirable
Background in Quality Systems in commercial biologics or cell therapy in an FDA regulated environment (i.e. investigations, change control, internal/external auditing, documentation, training, quality control labs, or bulk manufacturing).
Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g. Trackwise, SAP, LIMS, Documentum)
Internal Number: R1538057
About Bristol Myers Squibb
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.