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

As a Quality Assurance & PAP Manager, you are the management representative for GxP quality, to advise the Country President and as Marketing Authorization (MA) accountable person, of license to operate status of the country. Theis role also supervise the execution and governance of Patient Access and Affordability Programs.

Key Responsibilities

Quality Assurance

• Ensure effective operational implementation of the QMS across all GxP areas and appropriate functional QMS elements are in place and described in the local Quality Manual

• Ensure GxP compliance is transparent to CP and Area by active liaison with GxP Quality Leads.

• Report GxP compliance status to CP & MC Leadership Team through the MC Management Review meeting.

• Manage product supply, distribution activities and handle Post Marketing Surveillance processes.

• Supervise critical metrics in the related GxP area and proposing remedial and improvement actions

• Identify trends and communicate identified risks. Liaise with regulatory bodies/teams and resolve issues within area of responsibility.

• End to end ownership to resolve quality issues and coordinate with key partners to reach a resolution.

Patient Access & Affordability

• Develop and continuously improve on the process for management of PAPs with adherence to AZ and industry codes of

• conduct, ethics, PhAMA code & relevant laws

• Build an effective PAP team.

• Monitor & interpret the local & global environment for significant changes & communicate implications of such changes to key stakeholders.

• Proactive cross-functional teamwork contributing to patient centric outcomes.

• Ensure that all documentation is compliant with the Malaysian Personal Data Protection Act (PDPA)

• Requirements

• You have a Bachelor’s Degree in Science or any related field.

• You should have 4 years of proven experience in a QA and/or QMS managerial role.

• Preferably with experience in the pharmaceutical industry, FMCG industry may be considered.

• Experience in manufacturing would be an advantage.

• Proficient in QMS and NPRA’s GDP Guidelines.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.