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Sr. Director, Quality Systems & Compliance

Company: Bristol-Myers Squibb
Location: Summit
Posted on: November 26, 2022

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.The Sr. Director, Quality Systems & Compliance at the BMS Summit West Cell Therapy (CAR T) Manufacturing Facility in Summit, NJ is responsible for the development, implementation, enhancement, and continuous improvement of site Compliance and Quality Systems. The role will work collaboratively across BMS to ensure that all site Quality Systems and Compliance programs are successful in maintaining high standards of quality and compliance. The position oversees site Quality Systems, including Deviations, CAPAs, Change Controls, Complaints, Training, and Document Control. Additionally, this individual will lead all aspects of site Compliance and readiness, including leading internal audits of the manufacturing facility, warehouses, and labs, managing health authority inspections (e.g. FDA, EMA, Health Canada, PMDA), maintaining a site compliance risk register, proactively identifying site compliance events or trends, conducting gap assessments against standards and regulations, leading fact-finding meetings, communicating the status of significant quality events to senior leadership, authoring health authority compliance notifications (e.g. Biological Product Deviation Reports (BPDRs), EU Product Defect Notifications and Recalls) and ensuing that the site maintains a constant state of inspection readiness. The role is also responsible for leading the site Quality Management Review program, reporting quality metrics, and representing the site in the Global Quality Council. As a senior member of the S12 Quality Leadership team, the Sr. Director, Quality Systems & Compliance, Cell Therapy Manufacturing may serve as a delegate and proxy for the Head of Quality, Cell Therapy Manufacturing, and is a champion for quality principles and compliance within the organization. This role is stationed in Summit, NJ, and reports to the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.Responsibilities:

  • Implement BMS's overall Quality Management System (QMS) and quality manual, policies, and procedures within the Summit West CAR T manufacturing site. Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents, and industry best practices and expectations.
  • Provide cross-functional quality leadership and act as a GXP compliance subject matter expert. Serve as the site's Quality business process owner for, at a minimum, Deviation Management, CAPA Management, Change Control Management, Product Quality Complaint Management, Notifications to Management / Escalations, Complaints, Quality Management Reviews, Internal Audits, External Audits, and Health Authority reporting (e.g. BPDRs, EU Product Defect Notifications, etc.).
  • Oversee the performance and effectiveness of the Quality Systems listed as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.
  • Responsible to assess and monitor the health of the QMS for continuous improvement, while also leading cross-functionally in order to build a culture of quality across the site. Ensure continuous improvement and alignment with global GMP requirements and expectations.
  • Lead Quality Council meetings and monitor the state of control of the QMS. Report site Quality metrics to corporate functions as required and monitor compliance.
  • Oversee and host end-to-end site preparation and management of corporate audits and regulatory inspections.
  • Lead / Host Fact Finding meetings for any Significant Events within the manufacturing site, including hosting the meeting, solving issues of significance, proposing a path forward, and ensuring all documentation is recorded in the Quality Management System.
  • Proactively identify and document risk signals and trends, and stay up to date on current GMP regulations and standards in the EU, Canada, Europe, Japan and other countries, as needed.
  • Collaborate with cross-functional partners to ensure the timely and compliant resolution of GMP events (e.g., Deviations, Corrective and Preventive actions, Trends, etc.).
  • Evaluate business goals, identify improvement opportunities, utilize critical thinking, and apply problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
  • Develop departmental goals and ensure timely completion of all deliverables. Champion and foster a positive and successful quality compliance culture in partnership with the site Quality Leadership Team (QLT) and Senior Leadership Team (SLT).
  • Develops, drives budget, and organizational structure, and base business requirements to accommodate business needs. Develops and monitors performance and process metrics. Develops a foundation of highly capable, aligned, and engaged Quality professionals in the site, which maximizes the strengths of its members.
  • Provides direction, oversight, and development of staff. Assures that an appropriate talent pool is developed and succession planning in place to support current and future business needs.Skills / Competencies:
    • Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds, and cultures.
    • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
    • Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise mindset) and makes the best decisions for the whole.
    • Excellent influencing and negotiating experience and capabilities in a matrix environment.
    • Must be able to interact with senior leaders as such is seen as a highly regarded and a credible leader with the ability to interface with stakeholders in a matrix environment.
    • Strong project management and execution skills and can manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment. Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities and schedule's activities.
    • Has a proven track record of delivering results and is action-oriented.
    • Adapts to changing work environments, work priorities, and organizational needs.
    • Leads within the broader internal and external network and seeks to have an impact on organization-wide performance.
    • Embraces complexity but strives for simplicity.
    • Shares resources and makes difficult trade-offs to benefit the organization at large.
    • Creates a vision for the future by spotting strategic opportunities for breakthrough performance.
    • Translates the case for change into actionable plans for the organization.
    • Demonstrates smart risk-taking and personal resilience when implementing change.
    • Enables others to navigate change with confidence and in sustainable ways.
    • Generates trust by maintaining the highest level of consistency between their words and their actions
    • Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and mitigate unfavorable quality compliance trends
    • Demonstrated excellence in written and verbal communication and presentation skills.
    • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.Qualifications and Education Requirements:
      • BS in relevant Science or Engineering discipline or MBA
      • Minimum of 15+ years of management in a regulated industry.
      • Working knowledge of the business environment inside a site quality organization, across various roles (e.g.: quality operations, QC, Quality Systems, quality assurance, validation, regulatory, etc.).
      • Proven track record managing global health authority inspections, site inspection readiness, and remediation required.
      • Proven track record of successfully implementing and improving Quality Systems, ideally within a manufacturing facility.
      • Demonstrated Quality leadership through a cross-functional partnership to monitor key performance indicators and mitigate unfavorable quality compliance trends
      • Demonstrated experience building and leading exceptional Quality teams is required
      • 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 environmentPreferred Qualifications and Education Requirements:
        • MS in relevant Science or Engineering discipline
        • Experience in CAR T, Pharma, or Biologics
        • Experience in continuous improvement, operational excellence, and six-sigmaWorking Conditions: (US Only):A large proportion of work is performed in a typical office environment, with standard office equipment available and used, and work is generally performed seated in that environment. Some proportion of work which may require standing and walking for > 25%of the time during some intervals. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visitto access our complete Equal Employment Opportunity statement.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.

Keywords: Bristol-Myers Squibb, New York , Sr. Director, Quality Systems & Compliance, Executive , Summit, New York

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