QA manager – MCOQ China

This role is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities for China marketing companies for all the AZ product portfolio.  Participates in development of Global AZ MCOQ Quality Strategy and executes strategy for MCOQ and Marketing Company GMP/GDP aligned with AZ’s bold ambition strategy for market expansion, product launches and accessibility.

Core Accountabilities

Develop, support and drive excellence in MCOQ GMP&GDP Quality activities to maintain the local License to Operate.  

GMP&GDP quality contact for the country and maintains an effective governance structure to ensure oversight of quality activities. 

• Participates in defining the strategy for the commercial global markets ownership and execution of MCOQ  GMP and GDP Quality System and framework in country
• Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in country markets
• Supports local MC to deliver the license to operate, including but not limited to support for GMP&GDP/GSP audits and inspections, implementation effective self-inspection programs in the country of responsibility.
• Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are managed and closed on time, risks are identified and escalated to Global Quality.
• Represents Quality on cross-functional and cross SET teams and steering committees related to MC market
• Drive global standardisation, simplification, and improvement of MCOQ Quality business processes.  Develops and sustains a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
• Provide training, supporting and coaching structure for Quality MCOQ network roles
• Participates in strategy and objectives setting for the MCOQ organisation
• Accountable for compliance assurance and working to one set of GMP & GDP/GSP standards and processes, as well as common GxP process across the MC GxPs.
• Accountable for both GSP regulatory and AZ standards related to distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
• To be part of global vendor program management, support AZ finished products management and work with sending site QA, EQ and global cooperate quality.
• Demonstrated ability to work independently and in project settings to deliver objectives.
• Keeps own knowledge of best practices, industry standards and new developments in quality management up to date
• Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs
• Responsible for managing Quality Standards and expectations across a broad range of services in order to provide a high quality, timely and cost-effective service
• Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations
• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management
• Contribute to Quality function in developing quality management system to fulfil Good Supply Practice (GSP) and AstraZeneca standards to ensure continuous improvement.
• Responsible for the assessment and implementation of regulatory and AZ policy & standards requirements.
• For process and procedure impacted multiple areas, represent China MCOQ Quality to correspond with other function.
• Promotes a Quality Culture in the MC sets strategy in the region and locally for execution of GMP/GDP excellence.
• Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
• Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally
• Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring and appropriate level of compliance

Education, Qualifications, Skills and Experience

Essential

• Degree or equivalent professional qualification in related field
• Experience in quality assurance within a pharmaceutical manufacturing environment

Desirable

• Post-graduate qualification

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.