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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:

This position reports directly to the Senior Director, Cell Therapy Compliance and is responsible for working collaboratively across the Cell Therapy organization to provide strategic GxP compliance support to assure adherence to global health authority requirements across the product lifecycle.

The Cell Therapy Compliance Leader will advise the Cell Therapy Operations and Development and Cell Therapy Franchise organizations on compliance matters such as regulatory notifications, drug shortage, market action fact finding investigation and associated market action activities. The position is responsible for advancing a Compliance Excellence mind set and has a unique opportunity to support and lead transformational change supporting BMS' journey to a culture of excellence.

The Cell Therapy Compliance Leader will work collaboratively with relevant Global Process Owners and leaders representing Cell Therapy in support of creating new and revised policies and procedures, and participate, as needed as an SME in BMS' PEARL process which assesses evolving regulatory changes.

Key Responsibilities:

The Cell Therapy Compliance Leader reports directly to the Senior Director Compliance, with job responsibilities that include but are not limited to:

• Cell Therapy Process owner for assigned Compliance Processes such as:

• Health Authority Reporting - Biological Product Deviation Reporting, Defect Notifications, Drug Shortage

• Notification to Management and Market Action recall process

• Support Commercial and Clinical (Investigational Medicines) North America (US, Canada) and Asia Pac (Japan, Australia, S. Korea Taiwan) in Compliance related events

• Support Cell Therapy Tier 2 Quality Council logistics/reporting; Represent Cell Therapy Compliance at relevant Tier 3 Quality Councils as assigned, collaborate with Global Performance Management on integration of Cell Therapy into enterprise metrics reporting

• Work with Internal and External Manufacturing Quality teams to assist in the strategic preparation for and management of global regulatory inspections as required and using principles of Quality Risk Management. Assist in the review of written responses to regulatory inspectional observations and/or health authority reports, as requested.

• Review all Cell Therapy Notification to Management events to proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement and to ensure compliance now and in the future.

• Work collaboratively with the Governance and Performance Management leaders to monitor quality and compliance operational leading and lagging performance indicators across the Cell Therapy network, periodically review compliance and quality operational metrics across the Cell Therapy network to proactively identify emerging trends, including the development and implementation of appropriate action plans to ensure continuous improvement as well as compliance now and in the future.

• Working with and across the Cell Therapy network, generate new approaches to advance a Compliance Excellence mindset.

• The Compliance Leader will work collaboratively to assess current Cell Therapy processes and procedures to ensure that they meet and/or exceed compliance requirements.

• The compliance lead will also participate, as needed as an SME in BMS' PEARL process which assesses evolving regulatory changes.

• Seek opportunities to work collaboratively with peers and other stakeholders to identify areas for enhancement and develop and implement cohesive solutions that benefit the broader organization.

• Inspire transformative thinking and motivate employees to deliver transformative performance

• Lead and/or participate in the sharing of best practices and lessons learned to embrace evolving regulations/expectations.

Qualifications & Experience:

• B.Sc. or BA in Natural Science (Chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science).

• Master or advanced degree preferred.

• Minimum of 10+ years of experience in the biopharmaceutical Industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority.

• Experience leading or supporting clinical and commercial manufacturing sites through global health authority inspections is desirable.

• Ability to identify and implement phase-appropriate compliance strategies to support the E2E product lifecycle.

• Demonstrated ability to apply effective risk management approaches that provide a proactive means of identification and control of potential quality issues.

• Demonstrated experience leading through influence and working in cross functional / matrix teams to investigate and manage quality and compliance related issues.

• Demonstrated ability to make and act on decisions while balancing speed, quality and risk.

• Ability to think clearly and in a decisive manner; remain calm under adverse conditions.

• In-depth knowledge of quality systems principles and applications.

• Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.

• Excellent oral and written communication skills.

• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.

• Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.

• Pragmatic in approach with demonstrated ability to make sound, risk-based decisions

• Ability to travel up to 25%

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The starting compensation for this job in Seattle, WA is a range from $194,000-$242,000 , 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 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.

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.

Company: Bristol-Myers Squibb

Req Number: R1586523

Updated: 2024-10-26 04:29:47.973 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.