Director Quality Control

Johnson & Johnson Innovative Medicine-posted 3 days ago
Full-time • Manager
Raritan, NJ
5,001-10,000 employees
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Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Quality Control, CAR-T Manufacturing! This position will be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. The Quality Control Director for an Advanced Therapy CAR-T facility leads the relevant laboratories in order to deliver testing and release while maintaining an environment of continuous improvement, customer focus and awareness of business needs. This role supports a diverse lab group which provides key services to the wider Advanced Therapies platform as well the Lenti and CAR-T local facilities. The role crafts long-term strategies, and advises a team of managers within the overall Quality Control department. Experience in the following: Analytical Testing, Microbiological testing, in-process testing & Quality control excellence/lab support.

  • Develops and implements strategy for cGMP’s compliance for the site.
  • Provides leadership and direction to Quality Control Team to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
  • Develops and champions an organizational culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
  • Responsible for appropriately staffing and developing the QC organization to meet business needs and succession plans.
  • Leads launches of new products and technology transfer across the platform.
  • Anticipates and plans for future requirements and agility in the Labs, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency and optimization objectives and anticipated changes needed to reflect future demand.
  • Establishes effective partnerships with other individuals, departments, and cross- functional teams so that analytical services are well understood and coordinated.
  • Establish proper communication channels to lead and mentor employees to higher levels of management capability and provide strategic leadership to further strengthen the QC operations.
  • Develops and controls budget, organizational structure, and business requirements to accommodate budget and assure metrics are met.
  • Ensure all activities are performed in accordance with GMP in the laboratories, and monitor QC compliance through robust internal audit and leadership oversight programs (e.g. GEMBA).
  • A minimum of a bachelor’s degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, or related Science or Engineering.
  • 10 years of proven track record in biologics and/or cell therapy Quality Control laboratory operations, with 5 of those years managing at the senior level.
  • Demonstrated success in leading a large scale QC lab.
  • Experience in hosting global regulatory agency inspections and successfully communicating quality control programs to regulatory reviewers.
  • Experience with Trackwise and eLIMS.
  • Excellent communication, interpersonal relation, collaboration, and influencing skills.
  • Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • This position is eligible to participate in the Company’s long-term incentive program.
  • Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
  • Holiday pay, including Floating Holidays –13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • 10 days Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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