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.

This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures. This individual will be responsible for leading the continuous inspection readiness efforts and the site’s self-inspection program.

Shift Available:

• Monday - Friday, Hybrid role

Responsibilities:

• Directs quality oversight of compliance and quality systems activities including Quality Risk Management, Data Integrity, Training, Audits and Inspections, Document and Records Management and Site Quality Council.

• Leads the local process owners for Quality Systems (deviation, capa, change control, data integrity, training, risk management, and audits).

• Ensures that all Compliance & Quality Systems personnel have adequate training, education and experience to perform their GMP related job function effectively.

• Leads and facilitates Health Authority inspection approvals of the facility and products.

• Leads the site self-inspection program to ensure that the site meets current regulatory and BMS corporate requirements.

• Provides training programs for auditing and various GMP compliance topics.

• Manages responses and leads efforts for all CAPA/lessons learned from audits and inspections.

• Provides leadership, guidance and problem-solving skills.

• Manages the Quality Council by sponsoring and driving Quality initiatives that directly impact the Site operations.

• Oversees all quality metrics tracking.

• Manages the site Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.

• Ensures compliance with regulatory commitments.

• Ensures compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.

Knowledge & Skills:

• Proven record with the successful implementation and management of the Quality System in a sterile, biologics or cell therapy commercial manufacturing facility.

• Expertise in GMP compliance, Quality System and global GMP regulations; must also have strong knowledge and experience with Quality Risk Management.

• Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and timely mitigate unfavorable quality compliance trends.

• Demonstrated experience building and leading exceptional Quality teams is required.

• Demonstrated excellence in written and verbal communication.

• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment.

Basic Requirements:

• BS/MS in relevant Science or Engineering discipline

• Minimum of 7 years of experience with being Manager of Managers (tiered leadership).

• Minimum of 10 years of experience with biologics health authority inspections experience.

• Minimum of 5 years of experience with leading health authority inspections.

• Minimum of 10 years of experience within a Quality System and Compliance or equivalent Quality roles.

#BMSCART, #LI-Hybrid

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/ (https://careers.bms.com/eeo-accessibility) 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: R1580664

Updated: 2024-05-04 01:22:13.353 UTC

Location: Summit-NJ

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.