Malaysia Affiliate Quality Lead

7 months ago


Petaling Jaya, Malaysia AstraZeneca Full time

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.
- 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.

**Key Responsibilities**

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 stan



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