AstraZenecaR&DAssociate Director, Clinical Quality Management, R&D Development Operations Division

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 standard
o 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 AstraZenecas preferred work environment including adherence to AZ Code of Ethics

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

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

Bachelors 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 Whats 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 JapaneseNative Level

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

キャリアレベル / Career Level

E

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.