Job Title: Associate Director, External Quality

Introduction to role:

Are you ready to make a significant impact in the world of pharmaceuticals? As the Associate Director of External Quality, you will be at the forefront of ensuring the highest standards in Quality Assurance distribution processes and Quality management enablement across the region. Your role will involve executing and continuously improving our quality management system, being responsible for quality performance, handling issues, and supporting GMP/GDP capability development in distribution processes and at distributors. Join us in shaping the future of life-changing medicines!

Accountabilities:

Support implementation of AZ Global Standard for GMP and GDPTrain and educate stakeholders of GDP/GMPImplement the Distributor Management Framework and ensure that distributors are authorized/licensed to conduct business related to AZ productsImplement and monitor processes related to handling of AZ productsIdentify risks and set corrective actionsMonitor Quality Performance among carriers, Distributors, and DCsEstablish new distribution routes with novel requirements and adapt to short notice changes (RRA)Support qualification of multiple cold chain solutions and associated change controlIntroduce new storage and distribution facilitiesEstablish and execute a robust rapid response process for responding to TE and S&L incidents during distribution of AZ productsPerform and document robust Quality Risk Assessment when deviations from standard processes occurConduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to GDP/GMP roleComplete all required training on SABA, Code of Conduct, supporting Policies, and SOPs on timeReport potential issues of non-complianceEnsure and monitor compliance by team members and third parties by:Positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and SOPsEnsuring completion of all required trainingFostering a culture of openness where employees are comfortable raising Quality questions or concerns and take action to bridge GDP/GMP quality gapsImmediately addressing and reporting instances of non-compliance & Implement (CAPA) Corrective action & preventive actionsEthical Conduct and Compliance, and SHE accountabilitiesUnderstand & Comply with legal and regulatory requirements related to GDP/GMPEnsure that GDP/GMP local & global SOPs are followed among team members to ensure GMP/GDP adherenceSupport Audit & Inspections with relevant GDP/GMP documents

Essential Skills/Experience:

Holding a bachelor’s degree in scientific/technical fieldMinimum five years of operations or quality assurance experience within Pharma industry, GMP or regulated environmentProven leadership and project management/implementation experience record.Strong demonstrated knowledge of cGMPs/GDPs, Quality Systems, and the pharmaceutical supply chainProven decision-making skills, judgment, and problem-solving skillsDemonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams in the Region and globallyStrong communication and technical writing skillsAbility to travel as required approximately 10-20% of the time.

Desirable Skills/Experience:

Previous experience negotiating business and quality contractsGlobal experience5+ years’ experience in Quality AssuranceAdvanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologiesAdvanced degree such as Masters in scientific/technical field, Business, or Quality Assurance/Regulatory AffairsMulti-lingual capabilitiesEducational qualification/certification in supply chain managementExperience of working with a health authority/regulatory body

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find yourself immersed in an environment where innovation thrives. With constant new products and launches, we are driven by a shared passion for delivering life-changing medicines. Our collaborative spirit encourages idea-sharing and problem-solving, ensuring that we stay ahead in rapidly changing markets. Here, you'll have the opportunity to make a real impact while working alongside a diverse team committed to excellence.

Ready to tackle this exciting challenge? Apply now to join our team at AstraZeneca!

Date Posted

28-Apr-2025

Closing Date

15-May-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.