Tokyo Genmab
Job Summary: Implement and promote GQP operations, establish systems for record management, collaborate with Global QA and Supply Chain, and handle antibody drug operations as MAH QA function.

Responsibilities:
  • Implement and promote GQP operations (Release control, manufacturing site control, preparation of necessary documents, quality information control, change control, quality agreement, etc.)
  • Establish a system including record management in anticipation of future renewal surveys of the marketing business
  • Collaboration with Global QA and Supply Chain (Deployment of Genmab Global policy to Japan, communication of necessary matters in Japan to Global, establishment of better SOPs in collaboration with Global)
  • Operations as MAH QA function that handles antibody drugs

Organization and Position:
  • Genmab has a CMC in the Regulatory Affairs (RA CMC) and CMC in charge of supply chain and technology-related operations. QA and CMC are independent in the Global organization but integrated in Genmab KK (Japan)
  • The position is GMP QA and includes GMP but GMP operations are not performed, though overseeing manufacturing sites as GQP of MAH
  • Our company does not have own manufacturing plant, all manufacturing is performed by CMO in Japan and overseas
  • Our development is focused on antibody products

Essential Experiences and Skills:
  • Broad knowledge and experience of GQP (operations in contact with MAH QA on the manufacturing site side are also acceptable)
  • QA experience in GQP or GMP (3 years or more)
  • Business English (email, document check, etc.)

Desired Experiences and Skills:
  • Actions relating to GMP Compliance Inspection, Foreign manufacturers accreditation (FMA) and maintenance of business license (MAH, Manufacturing license, etc.)
  • Business / communication with Global functions, manufacturing sites, etc.
  • Experiences to use Software generally used as MAH QA (Document management system, Quality information registration systems, etc.)
  • Valid working visa or permanent residency in Japan.
  • Native level Japanese in verbal, reading, & writing.

Company Culture: Genmab values teamwork, inclusivity, and open communication. We promote diversity and foster an environment where employees from different backgrounds can work together to achieve our goal of improving cancer treatment.

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