The Role & Department

• 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.), continuous improvement
• Collaboration, instruction, and guidance on quality with subcontractors (Explanation of Japanese requirements, audit, change control, deviation control, etc.)
• 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)
• Establishment of Marketing QA Department that handles antibody drugs, and practical lead
• Actions for new product introduction (responding to inquiries PMDA when applicable, cooperation with new CMOs, GMP compliance inspections, etc.)

Knowledge and skills required

• Broad knowledge and experience of GQP (operations in contact with MAH QA on the manufacturing site side are also acceptable)
• QA experience of pharmaceutical companies (5 years or more)
• Business English
• Communicating effectively with others (i.e. co-workers, authorities, etc.) to achieve win-win situation.
• Demonstrated ability to build and foster teamwork, and strong ability to work across functions; strong relationship building skills.

About You - additional qualities you bring to the table

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted in science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

• Permanent residency in Japan
• Native level Japanese in verbal, reading, & writing