Associate Director, External Quality

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 GDP
• Train and educate stakeholders of GDP/GMP
• Implement the Distributor Management Framework and ensure that distributors are authorized/licensed to conduct business related to AZ products
• Implement and monitor processes related to handling of AZ products
• Identify risks and set corrective actions
• Monitor Quality Performance among carriers, Distributors, and DCs
• Establish new distribution routes with novel requirements and adapt to short notice changes (RRA)
• Support qualification of multiple cold chain solutions and associated change control
• Introduce new storage and distribution facilities
• Establish and execute a robust rapid response process for responding to TE and S&L incidents during distribution of AZ products
• Perform and document robust Quality Risk Assessment when deviations from standard processes occur
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to GDP/GMP role
• Complete all required training on SABA, Code of Conduct, supporting Policies, and SOPs on time
• Report potential issues of non-compliance
• Ensure and monitor compliance by team members and third parties by:

• Positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and SOPs
• Ensuring completion of all required training
• Fostering a culture of openness where employees are comfortable raising Quality questions or concerns and take action to bridge GDP/GMP quality gaps
• Immediately addressing and reporting instances of non-compliance & Implement (CAPA) Corrective action & preventive actions

• Ethical Conduct and Compliance, and SHE accountabilities
• Understand & Comply with legal and regulatory requirements related to GDP/GMP
• Ensure that GDP/GMP local & global SOPs are followed among team members to ensure GMP/GDP adherence
• Support Audit & Inspections with relevant GDP/GMP documents

Essential Skills/Experience:

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

Desirable Skills/Experience:

• Previous experience negotiating business and quality contracts
• Global experience
• 5+ years’ experience in Quality Assurance
• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies
• Advanced degree such as Masters in scientific/technical field, Business, or Quality Assurance/Regulatory Affairs
• Multi-lingual capabilities
• Educational qualification/certification in supply chain management
• Experience 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!

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.