Director, Quality Assurance Operations Cell Therapy

Posted an hour ago
Main Location
New York City, NY, United States
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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.

Job Summary:

Bristol Myers Squibb is seeking a Director of QA Operations at the Cell Therapy Facility (CTF) in Devens, MA.  This individual will be responsible for building the team responsible for providing Quality oversight of procedures and Quality Risk Management of the startup of the Devens CTF.  Following startup, this role will be additionally responsible to provide senior leadership to the QA Operations organization and oversee the QA Field, QA Warehousing and Disposition organizations.

 The Director of QA Operations will be a key member of the CTF Quality Leadership Team and a champion for quality principles and compliance within the Devens Cell Therapy organization.
This role reports to the Executive Director of Quality for the Devens Cell Therapy Facility.

Job Responsibilities:

  • Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
  • Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business unit and Quality goals and objectives.  Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.   
  • Directs the quality oversight of operating procedures for the Devens CTDO quality assurance program which assures effective floor quality presence in the Cell Therapy Facility (CTF) Manufacturing and Warehousing operations
  • Directs the quality oversight of start-up activities including approval of testing methods and associated process and laboratory technical documentation. 
  • Directs the QA support for ongoing validation activities for equipment, cleaning, sterilization, and process qualification and validation.
  • Directs disposition of raw materials and cell therapy final product.
  • Participates in the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
  • Ensures that all QA Operations personnel have adequate training, education and experience to perform their GMP related job function effectively.
  • Ensures all executed batch production reports and laboratory testing results are reviewed and approved before release of the product to assure that no deviations have occurred, or if deviations have occurred, that they have been investigated.
  • Provides appropriate information to, and obtain the Qualified Person’s approval, as required by the specific European Union (EU) regulatory authorities.
  • Ensures an effective process / system for disposition of cell therapy products is in place.
  • Ensures an effective system for returns and salvages that include assessment, investigation, and disposition.
  • Participate in BPDR investigations, as required.
  • Directs oversight to ensure shop floor walk through audits are completed and challenge adherence with area procedures, coaching and Quality support in alignment to the business unit to optimize compliance and efficacy.
  • Ensures the designation and monitoring of storage conditions for quarantine materials and products.
  • Ensures alignment among QA shop floor oversight, Quality Systems and product disposition functions.
  • Supports the resolution of product and process issues associated to Quality Events.
  • Supports Technology Transfer initiatives.
  • Leads the Material Review Board.
  • Ensure that recall operations are capable of being initiated promptly and at any time. This includes that lists are maintained of customers, of all batches distributed and of distribution information. The rapid availability of this information must be periodically checked.
  • Ensures an effective process is in place for reserve sample collection and storage.
  • Ensures that a process / sampling program are in place.
  • Ensures all necessary testing is carried out.
  • Uses results of testing performed in the Incoming Materials Area, Analytical and Microbiological laboratories and vendor documentation for the disposition of materials.
  • Supports Process / Manufacturing decisions during audits with regulatory agencies.
  • Serves as a Quality liaison with internal and external customers.
  • Reviews and approves procedures related to process, products, utilities, and laboratories.
  • Prepares site Key Performance and trending metrics.
  • Verifies compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications.

Qualifications and Education Requirements:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required
  • A minimum of 10 years experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility.
  • Experience in building and growing an organization into a high performance team.
  • Strong background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with direct accountability for investigations and change control programs.
  • Knowledge of cell therapy, biologics manufacturing or analytical testing is highly desirable.
  • Extensive knowledge of US and EU cGMP regulations and guidance.
  • Extensive and proven experience in FDA (or other regulatory authority) Preapproval Inspection preparation and management is essential.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva.
  • Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable.

BMSCART

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.

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Director, Quality Assurance Operations Cell Therapy
Bristol Myers Squibb