転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です
Quality Assuarance, Senior Manager （品質保証シニアマネージャー）
年収：応相談
採用企業案件
アムジェン株式会社
-
- 会社規模非公開
- 医薬品メーカー
| 部署・役職名 | Quality Assuarance, Senior Manager （品質保証シニアマネージャー） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
The Senior Manager of Quality Assurance at Amgen leads the QA department and plays a crucial role in establishing, implementing, and maintaining the Quality Management System. They ensure the organization's compliance with regulatory standards and drive continuous improvement initiatives. 【Responsibilities】 • Lead the QA department and play a crucial role in establishing, implementing, and maintaining Quality Management System. • Establish drug GQP and QMS operating policies and organizational structure per Amgen GxP, Policies and Procedures, and government regulations- products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices and small molecules in solid oral dosage form. • Accountable for compliance with Amgen GxP, Policies and Procedures, and government regulations • Confirm products to be dispositioned conform to applicable requirements including GQP ordinance requirements and perform disposition of products to Japan market. • Manage GxP processes such as Batch Release, CAPA, Change Control Deviation, Self-inspection, Training, Complaint, Recall, Quality Agreement, Oversight on manufacturers etc. • Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities. • Provide guidance and technical advice for PMDA Inspections that impact Amgen sites, as needed. • Quality oversight of Contract Laboratories, Distributors and Logistic Service Providers as needed. • Development and management of the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements; as delegated, represent Amgen in key industry groups in Japan and provide Amgen stakeholders with guidance and interpretation on these requirements. • Engage with global teams to promote a clear understanding of Japanese regulatory requirements, regulatory authority expectations, and customer expectations. • Work with global teams to share good practices and to drive continuous improvement initiatives. • Act as a deputy of Head of Japan Quality and Quality Assurance Supervisor if needed. • Contribute to the Amgen K.K. (AKK) mission, vision and strategy. |
| 労働条件 |
【勤務地】 東京本社：東京都港区赤坂9丁目7－1 ミッドタウン・タワー39階 ※在宅勤務制度あり 【試用期間】 あり（3ヶ月） 【勤務時間】 9:00ー17:30（休憩１時間） 【フレックスタイム制度】 有（コアタイムなし） ※詳細については、フレックス勤務規定による 【社会保険】 各種社会保険完備 【交通費】 社内規定に則り支給 【退職金制度】 あり 【休日・休暇】 年間休日：126日 └土日祝休み、年末年始、その他 年間有給休暇：12日～20日 |
| 応募資格 |
【必須（MUST）】 ・Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities in a global commercial operation.• Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance, negotiation skills and oversight to monitor health of partnership. 【歓迎（WANT）】 • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources• Experience with Multi-National (MNC’s) as well as Japanese pharmaceutical companies • Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan • Experience with Investigational Medicinal Products (IMP) and commercial products • Experience with combination products in Japan • Preferred candidate either lived and or worked aboard. • Flexible to travel • Experience in GMP audits of laboratories that perform analytical testing of biologics, LSPs and manufacturing sites. • Pharmaceutical/ Biologics product commercialization and lifecycle management experience • Strong verbal and written communication skills in English and Japanese. • Knowledge of regulatory authority inspection processesConfidential Quality Assurance • Experience in Japan with multiple language capability (English, Japanese) • Strong verbal and written communications skills. Must be able to effectively articulate ideas with all levels of an organization. • Self-leadership and motivation with high personal integrity and application of Amgen Values in daily operations. • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff • Ability for travel to international destinations as needed |
| アピールポイント | 管理職・マネージャー フレックスタイム |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2026/02/05 |
| 求人番号 | 7182450 |
採用企業情報
- アムジェン株式会社
-
- 会社規模非公開
- 医薬品メーカー
-
会社概要
【代表者】スザナ・ムルテイラ
【本社所在地】東京都港区赤坂9丁目7番1号
【事業内容】治療薬の開発・製造
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です