Quality Systems Lead

3 hours ago

cambridge, United States MEDIPOST America, Inc. Full time

MEDIPOST is Korea’s largest and most trusted umbilical cord blood bank and a commercial-stage cell therapy company. We develop novel umbilical cord-derived stem cell therapies to treat degenerative diseases like Alzheimer’s, Diabetic Neuropathy, and Osteoarthritis.


Our flagship product, CARTISTEM, is the world's first allogeneic stem cell therapy for moderate to severe knee Osteoarthritis (OA). Approved in Korea since 2012, over 28,000 patients have been treated with CARTISTEM. We have recently partnered with the Centre for the Commercialization of Regenerative Medicine (CCRM) to form Omniabio, a cell and gene therapy CDMO in Toronto. With our expertise and experience, we are advancing a Phase III clinical program to expand CARTISTEM into North America and Europe.


As MEDIPOST embarks on a journey to halt degenerative diseases such as osteoarthritis, we are seeking a talented and experienced Director of Quality Systems who will ensure that DS and DP production for our Phase III trials and commercial supply are compliant with current quality and regulatory standards.


As the Quality Systems Lead, you are a seasoned individual in the field of GMP commercial and clinical phase manufacturing supply with a background in quality and regulatory compliance. You will have demonstrated effective leadership of successful Quality organizations, and your experience will include the manufacturing of biological Drug Substances and Drug Products. Ideally, you have experience in Advanced Therapy Medicinal Products (ATMP) and Contract Development and Manufacturing Organizations (CDMO).


The Quality Systems Lead is responsible for the quality operations and quality and regulatory compliance for MEDIPOST’s cell therapies from research through the clinic to commercialization, including the build-out of a phase-appropriate quality roadmap. The role will be responsible for supporting the development of the cell therapy quality strategy to meet business, regulatory, and operational requirements. Responsibilities include quality oversight for the quality disposition of products, from early clinical through the commercial stage and launch of products manufactured globally. The role will be tasked with ensuring clear communication and excellent team, internal and external operational stakeholder-partner relationship management to lead/support the development and execution of quality projects, quality & technical risk management, including execution of associated mitigation plans, and to participate in critical projects.


Qualifications:

  • Bachelors or Post-Graduate degree in Science, Engineering, or related discipline
  • Minimum 10 years in quality assurance management and compliance, ideally with cell therapy/viral quality systems, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
  • Experience in quality assurance and quality control operations role for allogeneic/autologous cell manufacturing process preferred
  • Global health regulatory agency knowledge and experience across GxP life cycle in Cell & Gene therapy and/or Biologics.

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