【AstraZeneca】【JOPS】Site Quality Lead, Senior Director Quality

•    Leads Quality function in a manner that maximises its contribution to the achievement of business objectives, profitability and return on investment. May have direct contribution to achievement of objectives across AstraZeneca more broadly.
•    Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit. 
•    Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency. 
•    Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through management reviews and through advocating continuous improvement. 
•    Is responsible for ensuring that the requirements and implications of all applicable external regulations and the AstraZeneca Quality Management System and Code of Ethics are understood and effective implementation processes are put in place in all parts of the business area for that is responsible for. 
•    Has technical oversight and responsibility for the quality and GMP/GDP compliance approaches and outcomes into the operations business area.
 •    Is responsible for ensuring the professional development of the organisation in order to provide sufficient qualified resources and strong succession pipeline for site quality function and wider network. 
•    Is responsible for ensuring that AstraZeneca is involved with and influential in key external organisations and events that interact with the government agencies that oversee and regulate the pharmaceutical development, manufacture and quality systems for medicines within Japan. 
•    Is responsible for the Management review process and outputs for the site and for ensuring appropriate management focus on quality and compliance topics affecting Japan Operations business.
•    Leads the Quality elements of change programmes and projects in their site, working with the business to prioritise delivery of the Global Quality strategy.
•    Optimises key relationships with organisations (e.g. external regulatory bodies and Quality networks) to take full advantage of efficiencies and meet compliance obligations.
•    Works in partnership with the business and specialist Quality colleagues to ensure that an environment of continued professional development is created and individual and team performance is managed effectively.

【経験/Experience】

- 必須/ Mandatory

•    Experience working within cross functional and global teams 
•    Track record of working with regulatory health authorities/ stakeholders/ government bodies / industry associations
•    Has managed significant risk, and has experience in applying robust judgement in high profile and high-pressure situations 
•    Has experience in change, budget and project management
•    Proven track record of attracting and developing talent, building capability and driving performance in direct and matrixed leadership roles 
•    Extensive work experience and deep understanding of culture(s) in Japan market 
•    Familiarity with the regulations in Japan

- 歓迎/ Nice to have

•    Lived and worked outside of Japan
•    Experience within a complex manufacturing/supply site environment
•    Experience in GQP roles

【語学・スキル・知識・学歴/ Languages・Skills・Knowledge・Education】

- 必須/ Mandatory

•    Fluent in Japanese and English
•    Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
•    Bachelor’s degree and substantial relevant experience in pharmaceutical quality, manufacturing or regulatory roles 

- 歓迎/ Nice to have

•    Ability to work externally and represent AstraZeneca with external industry associations
•    Effective problem and conflict resolution skills and proven team focus
•    Excellent knowledge of AstraZeneca policies, procedures and guidelines
•    Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills