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Senior Manager, QA Material Review Board

3 months ago

Summit, United States Bristol-Myers Squibb Full time

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Senior Manager, QA Material Review Board

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locations

Summit West - NJ - US

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R1581135

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 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

. 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 is a people leader responsible for the performance of the QA team that coordinates and leads the Material Review Board (MRB) meetings for commercial and clinical products manufactured at the NJ CAR T Summit (S12) manufacturing site. The Senior Manager is accountable for the completion of MRB deliverables in accordance with site and global requirements as well as they are responsible for the development and growth of the Material Review Board lead and associates. The Senior manager participates in continuous MRB process initiatives and represents the Summit (S12) Material Review Board within in the CAR T global network. Shift Available: Monday - Friday, Hybrid Day Shift

Responsibilities: Chairs Material Review Board (MRB) meetings. Reviews and approves MRB minutes and executive summaries and notifies senior leadership of any risks or delays to product release.

Approves post MRB documentation in the Quality Management System.

Oversees and approves procedures for the MRB program.

Leads day to day activities, develops skills, and supports career growth of all direct reports.

Updates and procures approval of job descriptions for department personnel. Ensures appropriate training for all direct reports.

Hires, develops, counsels, manages, and motivates staff. Writes and administers performance reviews for department personnel.

Performs notification to management when applicable.

Leads and critically review investigations, interpret results, and generate technical conclusions consistent with quality risk management principles.

Responsible for applicable trending of compliance metrics within the Material Review Board.

Represents Summit CAR T Material Review Board for meetings/projects both locally and within in the BMS CAR T network. Works with global partners to determine best practices for Material Review Boards across the BMS network.

Stays abreast of industry standards as applicable to cGMPs and global regulatory guidelines and requirements.

Acts as a Compliance and Right First Time Champion, resolving quality issues when applicable. Proposes solutions for complex issues and leads their resolution.

Proposes and leads continuous improvement initiatives to increase group and site efficiency.

Promotes a team culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving.

Completes requests from cross functional business partners on behalf of the MRB team.

Supports site and functional teams during regulatory inspections or audits, which may include direct interaction with inspectors/auditors as well as writing and/or reviewing responses.

Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

Serves as Material Review Board Subject Matter Expert for the team, site and network.

Knowledge & Skills: General understanding of cGMP, ISO, FDA, MHRA, PMDA, USP, ATMP, PDA and EP regulations and guidelines as related to the manufactured of cell therapy products.

General knowledge of CAR T manufacturing process (including process control strategies), product critical quality attributes and regulatory filing processes.

Proficiency in utilizing Microsoft Office applications including limited to Word, Excel, and PowerPoint.

Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

Advanced Knowledge of quality processes, including material disposition, change control, deviations, investigations, and CAPA management.

Excellent attention to detail.

Effective communicator and collaborator.

Proven problem solver.

Must have strong Quality acumen and RFT focus.

Advanced ability to interpret results and situations and provide meaningful recommendations for resolution.

Proven

continuous-Improvement

experience and delivery.

Adaptive, flexible and proven change agent expertise.

Proven influential leadership and ability to partner and influence leaders and functional areas at the site and global levels.

Basic Requirements: Bachelor's degree required, preferably in Chemistry, Biochemistry, Engineering, Microbiology or related science.

Minimum of 5 years working in quality operations within the biopharmaceutical, gene or cell therapy industries.

Minimum of 5 years working in quality systems investigations management.

Minimum of 3 years leading and managing people.

Minimum of 1 year experience working with KPIs.

Working Conditions: Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.

W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

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