Senior Manager, GMP and QA

ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。

JD for QA/CMC GMP QA position

Activity

• As MAH QA, 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 (scheduled for 2025).
• 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

[Note about the organization and the position]

• For Genmab, there is a CMC in the Regulatory Affairs (RA CMC) and CMC in charge of supply chain and technology-related operations. In the Global organization, QA and CMC are independent, but in Genmab KK (Japan), QA and CMC are currently integrated into one organization (QA/CMC). Although CMC is included in the organization name, CMC part of the application form is prepared by CMC of RA division. Since the CMC part of an application is relating to GMP compliance inspections, change control, etc., QA/CMC collaborates with the CMC of the Regulatory Affairs, but QA/CMC do not prepare the CMC part of NDA document.
• The position is GMP QA and it includes GMP, but GMP operations are not performed, though overseeing manufacturing sites as GQP of MAH.
• Since 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, 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 experience 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.

#LI-DNP

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