Senior Manager Quality Systems, Site Data Integrity Lead in Devens, MA

Senior Manager Quality Systems, Site Data Integrity Lead

Working with Us 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. 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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

The Senior Manager Quality Systems, Site Data Integrity Lead is responsible for ownership and oversight of the Data Integrity (DI) Program at Devens Cell Therapy. The Site Data Integrity lead will be accountable for designing and delivering a strategic vision for compliance deliverables, risk management, gap remediation, continuous improvement, and quality culture across the site related to Data Integrity standards. The ability to work cross-functionally with all levels of the organization, be an exceptional communicator, and influence without direct authority will be essential for driving best in class Data Integrity performance for Devens Cell Therapy.

Responsibilities:

• Establish, monitor, report, and drive action focused DI performance metrics for Site Management Review (Quality Council).
• Lead cross-functional DI Quality Governance Forum. Drive continuous improvement and strategic quality maturity planning. Oversee site "DI Champions" program.
• Ownership of site DI Master Plan. Lead associated annual remediation strategy/goal setting.
• Deliver front room support for Health Authority Inspections and Drive site DI Inspection Readiness solutions.
• Oversight of Data Integrity Risk Assessment (DIRA) program and lead role for FMEA facilitation.
• Collaboration with Network teams on bringing next-gen DI solutions to site.
• Establish best in class DI Culture through designing and delivering DI training solutions across all levels at the site.
• Perform and advise on DI Impact Assessments for potential high-risk deviations, change controls, and process risk assessments.
• Establish cohesion of quality objectives for site Data Integrity with other quality systems (Deviation, CAPA, Change Management, Risk Management, etc) to drive application of foundational Data Integrity best practices in daily operations across all departments.
• Maintain knowledge of evolving regulatory expectations related to Artificial Intelligence (AI). Operate as SME on application of BMS AI procedures and requirements for use in GMP manufacturing procedures.

Knowledge and Skills:

• Demonstrated ability to drive strategic innovation, measurable process improvements, and deliver to expedited project deadlines.
• Experience with Health Authority inspections and interacting with regulatory bodies within the biotech industry.
• Strong knowledge of cGMPs and domestic regulatory requirements pertaining to Quality Systems and Quality Risk Management (ICHQ10 and ICHQ9).
• Strong interpersonal skills with the ability to drive dynamic changes through collaboration with cross-functional stakeholders.

Basic Requirements:

• Bachelor's degree, preferably in a life science field; advanced degree preferred.
• Preferred: minimum 8 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment within biotech, cell therapy or pharmaceuticals.
• Preferred: minimum 4+ years of quality system experience or diversity of experiences leading quality focused initiatives.

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.

Compensation Overview: Devens - MA - US: $138,670 - $168,034. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our careers site.

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 a supportive culture, promoting global participation 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 an 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

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