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.

Experience in the manufacture of biologic drug substance (DS) is mandatory; experience in the manufacture of synthetic drug substance (DS) and/or drug product (DP) will also be considered.

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 Integral 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 drug substance (DS) is mandatory; experience in the manufacture of synthetic drug substance (DS) and/or drug product (DP) will also be considered.
- 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.

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. AstraZeneca offers an environment where your work is valued and impactful. With an unrivalled forward-looking mindset, you'll be at the forefront of innovation, learning how to add real value throughout the lifecycle of our products—from discovery to commercialisation. As the voice of the patient, every batch you certify is a personal stamp of approval.

We are committed to improving reliability and excellence in our processes through constant innovation and trailing new models and technologies. Here, you'll feel empowered to make decisions that prioiritise patient safety and quality.

Ready to take on this exciting challenge? Apply now and be part of our journey to deliver life-changing medicines!

Date Posted

18-ago-2026

Closing Date

21-ago-2026

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.

📌 Associate Director External Quality (Guadalajara)
🏢 MX10 ASTRAZENECA S.A DE C.V.
📍 Guadalajara