Company OverviewTop of global pharmaceutical company
Job DescriptionThe company is seeking an Associate Director QA Operations within the Global Cell Therapy Quality Unit to provide Quality oversight of Contract Manufacturing Organizations in support of the company’s Cell Therapy operations in Japan. In addition, this role will work collaboratively to provide support to the Responsible Person for Quality Assurance of commercial products (Hinseki) with respect to drug product disposition and distribution in Japan.
This individual will be a key leader within the Global QA Supply Chain organization, and represents the Cell Therapy Quality organization in regional committees and forums. This role is stationed in Tokyo, Japan and reports to the Head of Global QA Supply Chain.
Requirements- BS degree with a minimum of 10 years of biotech/pharma industry experience; a minimum of 5 years of managing Quality Assurance functions in a commercial Biologics or Cell Therapy drug product manufacturing facility
- Expertise in GCTP/GMP compliance and Japan regulations is required