Senior Manager, GMP QA (GQP QA)
Genmab
This job is no longer accepting applications
See open jobs at Genmab.See open jobs similar to "Senior Manager, GMP QA (GQP QA)" B Capital.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.)
Essential experiences, skills
- Response to GQP inspections (acceptance of administrative inspections)
- Experience in leading responses to product recall, etc.
- Experience of Quality Assurance Manager, deputy, and Deputy Quality Assurance Manager
- Experience with pharmaceutical manufacturing sites
- Experience of handling of market release including delegation to a domestic manufacturing site
- GMP audit experience (conducting or accepting audits)
- Actions for GMP compliance inspection by PMDA
- Actions relating to Foreign manufacturing site accreditation (FMA)
- Knowledge and experience of GDP (Good Distribution Practice)
- Quality building experience of new products (Coordination of criteria with manufacturing sites)
- Experience in communications with Health Authorities relating to various issues (Quality problems, Discrepancies with registration dossiers, stock-out/shortage, etc.)
- Experience with maintenance of business license (MAH, Manufacturing license, etc.)
- Experience in QA business with CMOs(new business and/or maintenance)
- Experience in handling quality complaints (Customer/HCP visits, etc.)
- Building a Supply Chain for New Products
- Experience of CMC part NDA document creation / review
- Japanese Pharmacist license
Requirements - what you must have
- Broad knowledge and experience of GQP (operations in contact with MAH QA on the manufacturing site side are also acceptable)
- QA experience of global companies (5 years or more)
- Business English
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。
This job is no longer accepting applications
See open jobs at Genmab.See open jobs similar to "Senior Manager, GMP QA (GQP QA)" B Capital.