Malaysia Affiliate Quality Lead

AstraZeneca is a leading global biopharmaceutical company. We believe the best way we can help patients is to focus on breakthrough science to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.

At AstraZeneca Malaysia, we aim to be the fastest growing pharmaceutical company in Malaysia in the therapeutic areas of cardiovascular, diabetes, oncology and respiratory. Through this ambition, we are confident that we can transform the lives of Malaysian patients by ensuring that they have access to life-changing medicines. Working here means being a member of our family in making a difference in delivering better health for Malaysian patients.

Job Description

• Is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all of the AZ product portfolio in Malaysia.
• Participates in development of Global AZ Affiliate Quality Strategy and executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility.
• Accountable for assurance of compliance with worldwide standards for all local GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.
  
  
  

Typical Accountabilities

For Malaysia, develop, support and drive excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.

 

Primary point of GMP&GDP contact for the Malaysia MC and maintains an effective governance structure to ensure oversight of quality activities.

• Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across market and commercial SET area as the Quality partner to Commercial SET leader, Regional Commercial Head and Global Safety.
• Participates in defining the strategy for the commercial global markets ownership and execution of Affiliate GMP and GDP Quality System and framework in Malaysia.
• Define, develop, deploy and monitor the GMP/GDP policies and standards and execution for in-country Malaysia MC.
• Accountable for a Malaysia Affiliate Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members.
• Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate Malaysia market.
• Drive global standardisation, simplification and improvement of Affiliate 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 regional Quality Affiliate network roles.
• Participates in strategy and regional objectives setting for the Malaysia MC Affiliate Quality organisation.
• Is the primary point of expertise for GMP & GDP activities impacting the Malaysia affiliate organisation.
• Plans, reviews and manages budget for the Malaysia Affiliate Quality organisation.
• Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Malaysia Affiliate GxPs.
• Accountable for Malaysia in-country specific regulatory requirements related to manufacture and 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.
• Responsible for Affiliate GMP&GDP input into divestments/acquisitions/licensing agreements in Malaysia MC.
• 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.
• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practice and regulatory requirements of own work and others work.
• Responsible for ensuring that policies and standards meet regulatory requirements
• Ensures compliance with Good Manufacturing Practice, Safety Health and Environment and all other relevant regulations.
• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams.
• Responsible for in-country preparation for Regulatory Agency and AstraZeneca inspections/audits and responses.
• Supports local Malaysia MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation effective self assessment programs in the country of responsibility.
• Responsible for ensuring QMS compliance and continuous improvement in Malaysia MC and all issues are managed and closed on time, risks are identified and escalated to Global Quality.
• Promotes a Quality Culture in the Affiliate sets strategy in the region and locally for execution of GMP/GDP excellence.
• Responsible for the achievement of Malaysia MC KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
• Adheres to Good Manufacturing Practice and Safety Health and Environment and ensures regulatory compliance.
• 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.
• The jobholders are directly involved with/lead working groups, teams, and projects to proactively provide a global perspective and to drive consistency and standardization in all matters related to quality and GMP compliance.
  
  
  

Education, Qualifications, Skills & Experience

• Degree level or equivalent
• Experience of GMP/GDP and Quality environment in Pharmaceutical and Medical Devices
• Strong communication and influencing skills
• Project and people management
• Understanding of multiple aspects of physical plant, technical equipment, and other elements of facilities management
  
  
  

Internal (to AZ or team)

• Members of all functions on project team
• Members of quality management function
• Understanding of multiple aspects of physical plant, technical equipment, and other elements of facilities management
  
  
  

External (to AZ)

• External service providers
• Regulatory bodies
• Pharmaceutical companies