Senior Manager or Manager, GMP QA (GQP QA)

Posted:
1/5/2025, 5:28:31 PM

Experience Level(s):
Senior

Field(s):
Operations & Logistics

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。

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

#LI-DNP

私たちは、社員ひとり一人が共通の目的に向かって、高い志を持ち、お互いを尊重し、共通の価値観をもとに日々仕事をしています。私たちの価値観の一つである誠実さを胸に、革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます。ジェンマブでは、がん患者さんの人生をより豊かにすることを目的に、部門や国境を超え、世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています。


互いを尊重して協力し合うチームワークは、ジェンマブの重要な企業文化であり、そのため世界中の社員が、インクルーシブ、オープン、協力しあう姿勢を大切に日々仕事をしています。地域、教育、文化、国籍、年齢、性別などを超えた多様性を推進し続けていくことが、企業が継続して成長していくために重要であると考えています。そのため採用においても、性別、年齢等に関わらず、スキルや能力をもとに多様性を重視し進めています。

ジェンマブ株式会社では、お客様の個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しております。ご応募いただく際は、個人情報の取扱いにご同意いただいた上、ご応募ください。

Genmab K.K

Website: https://genmab.co.jp/

Headquarter Location: Nagano, Nagano, Japan

Employee Count: 1-10

Year Founded: 2017

IPO Status: Private

Last Funding Type: Seed

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