Associate Director External Quality

The Associate Director External Quality is accountable for providing quality oversight and expert QA leadership across supplier-related projects from planning through execution, close-out, and handover into routine commercial supply.

As a key representative of Global Quality within cross-functional project teams, this role ensures GMP and regulatory compliance across activities related to supplier selection, new supplier establishment, technology transfer, validation, audit support, change control, deviation management, issue resolution, product launch, and ongoing supplier maintenance. The role also drives quality improvement initiatives across AstraZeneca and its external network, providing authoritative quality guidance in a complex, global, and highly regulated environment.

The position requires strong collaboration with international suppliers and cross-functional stakeholders across multiple countries and time zones, as well as willingness to travel up to 25% across the Americas region.

Typical Accountabilities

• Provide end-to-end quality oversight for supplier-related projects, ensuring compliance with cGMP , AstraZeneca quality standards, and applicable regulatory requirements throughout planning, execution, and close-out.
• Act as the project quality lead for activities related to new supplier selection , supplier establishment, strategic sourcing , and New Product Introduction projects.
• Support Quality Assurance activities for technology transfer , process validation, qualification activities, and product launch readiness at external manufacturing sites.
• Ensure quality oversight of CMOs , suppliers, and contractors supporting the manufacture of biologic and synthetic drug substances and drug products.
• Lead or support quality activities related to change controls , deviation investigations , issue management, risk assessment, and the implementation of corrective and preventive actions.
• Represent Global Quality within the External Supply & Manufacturing (ESM) organization and within the broader project management framework.
• Provide expert QA guidance to cross-functional teams and external partners to support robust decision-making and effective risk management.
• Drive continuous improvement initiatives across AstraZeneca and external suppliers to enhance compliance, quality performance, and operational reliability.
• Support audit and inspection readiness , including internal audits, supplier audits, and regulatory inspection support activities where relevant.
• Contribute to post-validation and post-launch activities , including post-approval changes , lifecycle management, and transition of products into commercial supply .
• Build and maintain effective relationships with global stakeholders, suppliers, and project teams to ensure alignment, accountability, and successful project delivery.

Education

A degree in a science or technical discipline such as Pharmacy , Biology , Chemistry , Engineering , or equivalent experience is required.

Qualifications, Skills and Experience

• Essential :
• Experience in the manufacture of biologic and/or synthetic drug substances or drug products .
• Experience in Biologics Drug Substance Manufacture .
• Experience supporting technology transfer and validation activities at contract manufacturing organizations .
• Broad Quality Assurance knowledge with relevant practical experience in pharmaceutical operations and/or development environments.
• Strong working knowledge of cGMPs , Quality Systems , and the pharmaceutical supply chain environment.
• Demonstrated experience working cross-functionally and leading significant improvement initiatives .
• Strong problem-solving and decision-making capabilities in complex, regulated environments.
• Excellent oral and written communication skills.
• Strong negotiation and influencing skills.
• Experience providing quality oversight to external suppliers, contractors, or CMOs .
• Ability to work effectively across multiple countries, cultures, and time zones.
• Willingness to travel up to 25% within the Americas region.

Desirable

• Experience in Sterile Drug Product Manufacture .
• Multi-site and multi-functional experience.
• Experience in Quality Assurance or in combined Quality and Technical roles.
• Knowledge of or certification in Lean Six Sigma .
• Experience collaborating with international suppliers or cross-functional teams across multiple countries in support of quality, technical, and/or supply chain objectives.
• Experience supporting post-approval changes , launch activities, and transition into commercial supply .

Equal Employment Opportunity

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.