Quality Associate Director, MCOQ

About the Company

Responsibilities

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