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  3. アストラゼネカ株式会社:【AstraZeneca】【R&D】Associate Director, Clinical Quality Management, R&D Development Operations Divisionの求人情報詳細

【AstraZeneca】【R&D】Associate Director, Clinical Quality Management, R&D Development Operations Division

アストラゼネカ株式会社

想定年収

1,130万円 ~ 1,550万円

勤務地

大阪府 東京都

仕事内容

■ 職務内容 / Job Description
Associate Director Clinical Quality Management (ADCQM) leads the planning and implementation of all quality activities adapting to changes in the environment through relevant Clinical Quality Management System. ADCQM is individual contributor and skill expert which meets organizational needs and professional role model for CQM. ADCQM is responsible for proactive contribution to Japan Development Operations(J-DO), and global member in Quality Management or Quality Assurance to develop capabilities to achieve high level of performance and productivity in Japan/global.

ADCQ is responsible for

• Contribute to the effective execution and implementation of the CQM, J-DO and R&D strategy.
• Lead the planning and implementation of all quality activities in J-DO through relevant Clinical Quality Management System.
• Drive the robust communications/networking with AZ global members to ensure our processes are aligned and that we are consistently applying processes and adapting to changes in the environmentin the document quality areas.
• Ensure Always Inspection Ready(AIR) including PMDA, EMA, FDA and other Health Authority inspection ready in Japan:o Guides study teams to adopt clinical study audit and inspection-ready standardo Collaborates with DOLT to ensure the all Clinical Studies delivered by J-DO are inspection ready and supports J-DO-related audits and inspections
• Lead to analyses and identifies improvement opportunities by collecting quality related data / quality issue (QI) and communicating with Process Owners(PO), System Owners, Subject Matter Experts and DOLT.
• Lead to assist study teams during development and implementation of CAPA plans and investigations.
• Provide a robust quality risk and issue management expertise to J-DO.
• Provides a compliance risk and issue management service to J-DO.
• Ensure that relevant new regulations are assessed and appropriately encompassed in J-DO.
• Build and maintain strong customer relationships with QA, Compliance Manager, PO, and DOLT etc.
• Leads keeping simplification and consistency of description in Procedural Document including Local SOP and working instructions, working package and training package within DO, R&D Japan and Global.
• Model behaviours that foster AstraZeneca’s preferred work environment, including adherence to AZ Code of Ethics

仕事内容変更範囲

会社の指示する業務

職位

募集背景

募集人数

1人

応募条件

技能/経験

【経験 / Experience】
<必須 / Mandatory>
'-Leadership of significant cross-functional change programmes/initiatives with Proven courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
-At least 5 years’ experience in the pharmaceutical industry including at least 3 years’ experience in Clinical Development / Assurance / Advice
-Well-informed understanding of drug development process and related GCP activities and understanding of skills and knowledge required for successful delivery of a clinical trial, e.g. GCP, monitoring, data management, study drug delivery etc.
-Proficient knowledge of local and international regulations and guidelines
-Knowledge of Clinical Procedural Documents

<歓迎 / Nice to have>
'-Process Management including developing / reviewing Procedural Documents in Japanese / English
-Professional excellence: Background of high professional achievement and willingness to encourage this in others
-Experience in leading or being involved with Business Process Management

【資格 / License】
<必須 / Mandatory>
Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.

<歓迎 / Nice to have>
MBA, Project Management Professional(PMP)

【能力 / Skill-set】
<必須 / Mandatory>
'-Leadership
-Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills in a multicultural environment
-Integrity and high ethical standards
-Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. 
-Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
-Makes effective decisions despite uncertainty and/or incomplete information.
-Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriate.
-Seeks diverse views and incorporates them where appropriate in order to develop better proposals and creative solutions for the business.

<歓迎 / Nice to have>
Consistently exhibits Leadership capability as below
-Commitment to Customers & Integrity; Focuses on What’s Important: Balances and prioritizes across diverse and competing customers, needs and opportunities. 
-Demonstrates the courage to make tough and ethical decisions about where to devote resources.

学歴

大学

職務経験

業界経験

年齢

年齢制限不問  

英語力

中級以上

その他語学力

語学力詳細

Business English (Achieve common understanding at the context level with customers, and at monthly global meetings)

勤務条件

雇用形態

無期雇用

試用期間

有り(6ヶ月)

給与

月給制

年収:1,130万円 ~ 1,550万円

月収:76万円~104万円

月額基本給:76万円~104万円

賞与・インセンティブ

年1回  

現在年収、経験により決定

昇給

有り 年1回 / 4月
年1回(4月)

勤務地

大阪府 東京都

出向

出向:無し

就業時間

09:00~17:15

休憩時間:1時間

残業:月30時間~40時間程度

管理監督職

残業手当

管理監督職のため、労働基準法41条により、労働時間、休憩、休日の割増賃金の規定は適用されません。

通勤手当

交通費:全額支給

その他手当

通勤費手当

休日・休暇

完全週休二日制, 年末年始

年間休日:125

年間有給休暇:入社7ヶ月目には最低10日以上
【有給休暇】※入社月により付与日数が異なります。詳細はオファー時に通知いたします
【休日・休暇詳細】
【有給休暇】※入社月により付与日数が異なります。詳細はオファー時に通知いたします

夏期休暇、年末休暇、慶弔、赴任、リフレッシュ、頭痛休暇等

社会保険

雇用保険, 健康保険, 労災保険, 厚生年金

福利厚生

退職金制度(確定拠出年金)、財形貯蓄、融資制度、慶弔見舞金、リスクベネフィット、健康診断、福利厚生倶楽部

受動喫煙対策

就業場所 全面禁煙

備考

※賞与につきましては、企業実績・個人実績によって異なります。

選考内容

選考プロセス

適性試験:無し 面接回数:2回

求人No.:NJB2360460

最終更新日:2026/2/13

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  3. アストラゼネカ株式会社:【AstraZeneca】【R&D】Associate Director, Clinical Quality Management, R&D Development Operations Divisionの求人情報詳細