Director, Cell Therapy Compliance

Company: Bristol-Myers Squibb
Location: Summit
Posted on: November 13, 2024

Job Description:

Director, Cell Therapy ComplianceApplyLocations: Summit West - NJ - US, Devens - MA - US, Seattle - WA - USTime Type: Full timePosted on: Posted 3 Days AgoJob Requisition ID: R1586523Working with UsChallenging. 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.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 mindset and has a unique opportunity to support and lead transformational change supporting BMS' journey to a culture of excellence.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.
  • Generate new approaches to advance a Compliance Excellence mindset.
  • Assess current Cell Therapy processes and procedures to ensure they meet and/or exceed compliance requirements.
  • 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%.Compensation: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.Benefits:Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit .
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Keywords: Bristol-Myers Squibb, Middletown , Director, Cell Therapy Compliance, Executive , Summit, Connecticut