Manager – Quality Systems and Compliance

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. Read more: careers.bms.com/working-with-us.

Key Responsibilities

• Manages and maintains administrative oversight of PD Quality Agreements, facilitating the creation and filing of new quality agreements in the document management system in addition to supporting periodic revision of existing quality agreements.

• Owns the local execution of the Deviation Monitoring and Deviation Evaluation programs; analyzes deviations across PD sites to identify trends and deficiencies and works with the sites to develop remedial actions as necessary.

• Authors, reviews and approves documentation. Monitors documentation activities performed in document management system. Supports and coordinates document periodic revisions as required within Product Development Quality.

• Supports the Document Management program by driving on-time completion of periodic document reviews, providing compliance and system support for PD/PDQ stakeholders, and general management of the QMS including daily maintenance, integrations, and go-live implementations.

• Supports the Management Review process through the collection, documentation, and reporting of PD metrics.

• Provides support for the PD Self-Inspection program by functioning as a support auditor when necessary.

• Provides support for all remaining PDQ QS&C functions where necessary, including Complaint Management, Quality Risk Management, Records Management, and Training Management.

• Supports quality harmonization and integration efforts across PD sites.

• Provides support for regulatory inspections/audits and internal audits, ensuring successful inspection readiness activities and compliance with health authority requirements.

• Build and foster strong relationships with stakeholders to meet the demands of a changing matrixed environment.

• Adheres to BMS core behaviors.

Qualifications & Experience:

Specific Knowledge, Skills, Abilities:

• Strong collaborative skills

• Effective written and verbal communication

• Computer literacy: Microsoft Office and other systems as required

• Addresses each event timely and properly and provides insight into potential business disruptions.

• Prioritizes when handling multiple work assignments and deadlines.

• Provides clear direction and priorities.

• Bachelor’s degree is required

• 5+ years of relevant quality experience in the life sciences industry is required

• Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations as they apply to clinical supplies

• Demonstrated interpersonal, communication, and motivation skills.

• Experience within a QA environment is required

Travel: This position requires up to 10% of travel

The starting compensation for this job is a range from US-NJ-$98,440 -$119,300 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

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 https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 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 [email protected]. 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/

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