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

Location Osaka, Ōsaka, Japan Kita-ku, Tokyo, Japan Job ID R-187585 Date posted 18/01/2024


Associate Director, Clinical Quality Managementは、Quality / Processの実質的責任者として臨床開発の重要な責務を担うポジションです。本ポジションは新設のポジションであり、新しいプロセスシステム構築のリーダーとして賢くリスクをとったプロセス最適化をリードすることで、組織全体の生産性向上を目指します。R&D組織内のステークホルダーをはじめ、他部署、グローバル組織との連携も多く、様々なスキルを磨く事ができるポジションです。Clinical Quality Managementのスペシャリストを目指される方からProjectManager、海外でのご活躍など、社内公募制度を利用し、異なる業種へ異動されるケースなど、多様なキャリアパスが想定されます。一緒に臨床開発の仕組から変革してみませんか?Quality Managementにパッションのある方からのご応募をお待ちしております!

■ 職務内容 / Job Description

Associate Director Clinical Quality Management (ADCQM), as an ad-hoc member of Japan Clinical Quality Management Leadership Team (CQMLT), is responsible for proactive contribution to CQM organization development and capability build. ADCQM is individual contributor, skill expert and professional role model for Quality Process Manager(QPM), and Clinical Development Associate(CDA). ADCQM is proactive contributor for global member in Quality Process Management or Quality Assurance to ensure Always Inspection Ready(AIR) including PMDA, EMA, FDA and other Health Authority inspection ready in Japan from quality process point of view and to develop capabilities to achieve high level of performance and productivity with the potential that can drive studies in Japan/global.
ADQPM is responsible for 
-Leading to establish new Procedural Document(PD) System/Framework in Japan Development Operations(J-DO), ie, maximum utilization of Global SOP with minimization of Local SOP / PD in Japan (including sharing with CRO) and transfer new PD System/Framework to be business as usual(BAU) though continuous improvement.
-Driving the robust communications/networking with AZ global members to ensure J-DO processes are aligned and that J-DO is consistently applying processes and adapting to changes in the environment.
-Developing/maintaining Japan specific PDs and training plan. 
-Conducting training for Japan specific PDs and others as quality process expert
-Giving answer on process-related question from DO staff from quality process point of view.
-Oversight quality activities in clinical studies in J-DO to keep high quality standards and processes toward the goal of inspection-ready.
-Maintaining, simplifying, and optimizing PDs in J-DO to align with J-GCP, ICH-GCP, related- laws and regulations, etc.

■ 応募資格(経験、資格等)/ Qualification (Experience & Skill etc.)

【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
-Business English

<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
-Line management experience

【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>

-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.

【語学 / Language】

<必須 / Mandatory>

日本語 Japanese:Native Level

英語 English:Business English (Achieve common understanding at the context level with customers) 

【キャリアレベル / Career Level】


【勤務地 / Work Location】

Osaka or Tokyo



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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