Site Quality Lead, Japan Operations

IMPORTANT NOTE: Hua Lei (hiring manage) ,currently registered under Kenya Shiozaki (HRBP) due to regional restrictions.

Accountable for professionally leading and managing the Quality Operations function within the Maibara Manufacturing facility, ensuring GMP, regulatory compliance and Quality Assurance for the quality of products packed and supplied to the Japanese market.

Leads the development and implementation of site strategy in conjunction with the Site Leadership Team.Ensure plant readiness for regulatory GMP/ GXP inspections.

Apply Quality risk management principles, utilising analytical skills and GXP experience to make decisions, develop solutions, drive system compliance or make judgements within operating guidelines.

Actively drives timely delivery of day-to-day Quality Operations within the site, ensuring adherence to plan and scheduler

Acts as a technical lead for the Quality Assurance function employing a deep understanding of GMP principles, manufacturing processes and equipment.

Leads the planning, managing, and monitoring of major quality projects and issues providing expert technical support to the assigned project manager.

Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs.

Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations.

Assures compliance of the site to regulations through establishing and maintaining compliance with all systems, processes and procedures in line with legislated requirements.

Act as the Recall co-ordinator for the AstraZeneca Japan business to ensure prompt and effective recall of any identified product from the marketplace.

Ensures that there is a training plan that enables personnel to obtain the knowledge and skills necessary for the execution of their tasks and that promotes professional development.

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 participation in management reviews and through advocating continual improvement.

Accountability for setting and significantly influencing site strategy

Oversees compliance of the Pharmaceutical Quality System, including monitoring compliance with the requirements of current Code of GMP.

• Tertiary degree or 5+ years prior experience in GMP manufacturing and quality management, including in process control or quality control

• Overall quality management system and GMP knowledge
• Expert of quality management system key process and quality risk management
• Project Management skill (planning, problem solving)
• Good collaboration, team coaching and people development capability
• Oral and Written Communication skills (J&E)
• Negotiation skill
• Facilitation skill
• Problem solving skill
• Leadership Capabilities (Level 2)
• Experience of computerized system and automation management

Experience of working cross functionally with groups such as regulatory affairs, manufacturing, global engineering, PTD, etc

• CMC-related special knowledge
• Knowledge of global GMP (FDA, EU) and ICH guideline
• Computer literate in Word, Excel, PowerPoint, Project and other applications

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 authorisation and employment eligibility verification requirements.