Job Description
このポジションは、薬機法に基づく総括製造販売責任者、およびGQP省令に基づく品質保証責任者としての責務を担います。また、当社のリーダーシップチームにおいては品質保証の責任者となり、医薬品の安全管理責任者と協力しながら製品の安全性に関する推奨事項の作成などを通じて継続的にコンプライアンスを確保します。 照合したバッチ記録と日本で実施した QC テストデータに基き、日本への輸入製品および日本での製造委託業者から供給される製品の品質を継続的にモニターし、確実な出荷につながるよう管理責任を持ちます。 安全性と品質に関する案件や突発事項などについて、関係省庁に適時報告します。
- アニマルヘルスの外部製造品質担当エグゼクティブディレクターの直属であり、グローバル外部製造品質チームのメンバーとなります。グローバルからの指導や指示を受けながら独立して責任を持ち、業務を遂行します。当該業務の進捗状況、改善機会、問題等について上司に報告します。
- 当社の総括製造販売責任者、及び品質保証責任者を務める。社内のリーダーシップ チームの一員としての責務を持ちます。
- ・QA組織、チームを管理します。
- ワクチンの国家検定について、定められた検査所と調整し、日本向けに輸入されたワクチンおよび医薬品のリリースに関する QC 検査およびバッチレビューを行う。
- 日本の製品登録書類および製造許可に適合する製品を受け取るため、日本とグローバルの薬事部門、および日本へ製品を輸出する製造拠点との調整・協力を行います
- 日本に製品を輸出する製造拠点との間で TQAが整備され、維持されていることを確認します。
- グローバルのアニマルヘルスクオリティマニュアルおよび日本のクオリティマニュアルが日本の現行規制要件を反映し、グローバルおよび日本のコンプライアンスをサポートしていることを確認。
- 社内および規制当局の監査(グローバル品質保証、HA、顧客)の主催を担当。
- クロスファンクショナルな調査やプロジェクトチームに効果的に貢献。
- 社内のR&Dや薬事申請書類の監査。
資格、スキル、経験
- 薬学の学士号、薬剤師免許。
- 日本語ネイティブレベル、英語力要(読み書き、スピーキング)
- GMPおよび薬事要件に関する豊富な知識経験、品質システム、品質保証、および品質管理に関する専門知識と幅広い経験
- サイエンスやデータ、および進化する環境における規制要件の理解に基づいた、優れた問題解決スキル、リスク管理対応力
- 薬学、分析化学、微生物学、無菌操作、cGMP、薬事などの専門知識
- ワクチンの製造および検査経験
- 多様な文化において人間関係構築、コミュニケーション、交渉力、説得力、リーダーシップスキルを示す能力、組織の複雑さや曖昧さに対処できる能力
- チームをリードし、動機付けなど、模範的な人材/チームのリーダーシップ経験
- パフォーマンス指標を確立し、結果に責任を持たせた経験
- ワクチンQC における経験と問題解決スキル。
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:12/31/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R281796
-
Software Engineering
1週間前
Chiyoda MUFG Full timeDo you want your voice heard and your actions to count? · Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), the 7th largest financial group in the world. Across the globe, we're 120,000 colleagues, striving to make a difference for every client, organization ...
-
Tokyo Elanco Full timeAt Elanco (NYSE: ELAN) – it all starts with animals · As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Li ...
-
Chiyoda Novo Nordisk A/SAre you a strategic leader with a commercial mindset? Are you interested in driving market access strategies for life-changing products and services? We are looking for a dedicated Local Market Access Senior Group Manager to join our team. If you are passionate about improving pa ...
-
Chiyoda MUFG Full timeDo you want your voice heard and your actions to count? · Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), the 7th largest financial group in the world. Across the globe, we're 120,000 colleagues, striving to make a difference for every client, organization ...
-
Account Manager
4週間前
Minato City Thomson Reuters Full timeReuters is looking for a dynamic and experienced Account Manager (Reuters Advertising Solutions) with a successful track record of meeting and exceeding annual sales goals to join our fully integrated sales team in Tokyo. Selling across Reuters' extensive award-winning platforms; ...
-
Chiyoda MUFG Full timeDo you want your voice heard and your actions to count? · Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), the 7th largest financial group in the world. Across the globe, we're 120,000 colleagues, striving to make a difference for every client, organization ...
-
Tokyo Yaruki Switch GroupContract Length: 1 year Number of Vacancies: 10 Eligible Candidates: University Graduate, Licensed Teacher, ESL Instructor · Requirements: Education Required: Associate/2-year Diploma · Criteria 1: Able to commit to a minimum 1-year Full-Time Contract · Criteria 2: Prior exper ...
-
Account Manager
4週間前
Tokyo Thomson Reuters Full timeAbout the Role · In this opportunity as Account Manager, Reuters Solutions, you will: High volume of weekly meetings with prospective agency/ client stakeholders; presenting Reuters and ensuring a solid understanding of account strategy and challenges. · In conjunction with the ...
-
Tokyo Thermo Fisher Scientific Full time: Work with RA/QA team to maintain and handle regulatory licenses of IVD/MD/AH (MAH, FMA, etc.) under the PMD Act and perform QMS activities. · Responsible for GVP operations for Medical Device (MD) /IVD products/ Animal Health products(AH) in Life Technologies Japan. · Collab ...
-
Country Manager
7日前
Tokyo World Courier K.K. Japan Full timeOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join ...
-
Tokyo Netflix Full timeNetflix is one of the world's leading entertainment services with 260 million paid memberships in over 190 countries enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywh ...
-
Tokyo BloombergMedia Sales Associate - Tokyo · Tokyo · Posted May 16, Requisition No · Smarter, Faster, and as always - First. That's our philosophy. Bloomberg Media empowers global business leaders with breaking news, expert opinion and proprietary data distributed on every platform, across ...
-
Tokyo Edwards Lifesciences Full timeRole Purpose: This position will drive the execution of Market Access strategies specific to the Edwards' BU portfolio of innovative therapeutic solutions for structural heart disease and/or advanced critical care technologies in Japan. The successful candidate will drive synergi ...
-
Tokyo Gensler Full timeAt Gensler, we design for people. We leverage our global perspective and local presence to innovate at every scale. We're not just designers. We're tinkerers, craftspeople, visionaries, innovators and thought leaders. Fueled by passion and entrepreneurial spirit, our people bring ...
-
Tokyo Illumina Full timeWhat if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are tran ...
-
Tokyo Thermo Fisher Scientific Full time· Responds accurately and professionally to technical and medical information inquiries received via · phone, email, internet, or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support ...
-
Tokyo Pfizer Full timeROLE SUMMARY · The Senior Director Public Affairs Japan is responsible for leading the Public Affairs function in Japan. This is a high-profile position, supporting Pfizer Japan's business leaders as well as C-suite executives. The role will provide strategic public affairs and ...
-
Tokyo Gilead Sciences K.K. Full timeDescription · Main Role Overview · Reporting to the Senior Director, Site Operations of Intercontinental, Japan, China and GPS, this role provides Facilities and Site Ops leadership and expertise to support the VP and Senior Leadership team in Japan. The Japan operation consist ...
-
Tokyo UNLOCK DESIGN Full timeWe are Unlock Design, a recruitment agency based in Japan, and the job description below is an opportunity with one of our forward-thinking client companies. We aim to ensure a trustworthy and considerate experience for our candidates, emphasizing their privacy and long-term care ...
-
Tokyo Turner & Townsend Full timeCompany Description · Who is Turner & Townsend? · All over the world people are using buildings, infrastructure, and assets we helped to deliver. It could be the hospital they work in, the railway they travel on every day, the fuel that powers their car or the data centre they ...
