■ 職務内容 / Job Description

The Director of Clinical  Quality  Management (DCQM), as a core member of Development Operations Leadership Team (DOLT), is responsible for:
・ providing directions advice on how to use the business processes and quality systems to the both Study Management and Site Management personnel to enable the delivery of projects according to agreed high quality standards and processes toward the goal of inspection-ready clinical studies.
・leading the planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions and keeping a breast of any business compliance issues and works in close collaboration with Quality Assurance (QA), Compliance Manager, Process Owner (PO), Process Partner (PP), DOLTand key regional and global networks.
・the maintenance and further development, and the communication of high-quality standards in the delivery of clinical studies.
・Ensure Always Inspection Ready (AIR) including PMDA, EMA, FDA and other Health Authority inspection in Japan including sponsor and site inspection.

Japan DOLT keeps overall accountability of quality and the DCQM ensures appropriate and close collaboration/communication with Japan DOLT and other functions for planning and implementation of the quality control activities for all clinical studies delivered by Development Operations department (DO).

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

【経験 / Experience】

＜必須 / Mandatory＞

・At least 5 years’ experience in the pharmaceutical industry
・Excellent understanding of the drug development process and related GCP activities
・Excellent understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP, study management
・Excellent knowledge of international regulations and guidelines, as well as AZ Procedural Framework

＜歓迎 / Nice to have＞

・Working experiences in Development Operations / Quality Assurance
・Line management experiences in R&D

【資格 / License】

＜必須 / Mandatory＞

・Bachelor’s degree required,  preferably in medical or biological science, or related subject or equivalent qualification or experience

【能力 / Skill-set】

＜必須 / Mandatory＞

・Ability to work in an environment of remote collaborators
・Good analytical, Strong leadership, problem solving, stakeholder management, negotiation and conflict resolution skills.
・Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships in order to operate across multiple domains enabling process and system harmonization and standardization
・Good people development
・Proven ability to transition between roles effectively and learn rapidly in a new environment.
・Influencing skills with well thought out rationale and effective communication skills, able to influence key decisions
・Conceptual Thinking by taking the longer term and global perspective into consideration and developing broad-scale objectives.
・Maintains high standards, including a commitment to AstraZeneca values, policies, and employment principles

【語学 / Language】

＜必須 / Mandatory＞

・英語 English：Fluent spoken and written English

【キャリアレベル / Career Level】

F level

【勤務地 / Work Location】

Osaka or Tokyo

Date Posted

Closing Date

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.