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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Summary

The Senior Manager, Compliance Cell Therapy 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 CTO 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.

Key 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).

• 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.

• Supports regulatory agency correspondence and filing submission activities.

• Leads Fact Finding deliverables for significant events (NTM) and supports BPRD submission as required.

• May lead APQR document coordination and authoring support for site.

Qualifications & Experience

• 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 regulated industry experience including 4 years of GMP Quality experience.

• ASQ Certified Quality Auditor qualification strongly desired.

• 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. Veeva, Trackwise, SAP, LIMS, Documentum).

#BMSCart, #LI-Hybrid, #Veteran

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1582262

Updated: 2024-06-21 03:31:01.700 UTC

Location: Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.