Associate Director Global Material Certification (Guadalajara)

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company renowned for the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. As one of the world’s leading pharmaceutical companies, we are committed to advancing science for the benefit of patients worldwide.

The Global Certification Group is dedicated to ensuring that Material Certification meets the highest standards and is delivered within agreed customer service lead‑times.

In this role, you will be instrumental in supporting the team by driving productivity through lean methodologies and providing technical expertise. As the Associate Director Global Material Certification, you will provide leadership in integrating quality into our supply chain, enabling efficient delivery of safe and effective medicines while meeting general regulatory expectations.

You will demonstrate your extensive knowledge of Quality Control and act as a Subject Matter Expert, focusing on enhancing our technical quality capabilities.

Accountabilities

• Team Leadership and Development: Lead and nurture a high‑performing team by fostering a culture of continuous improvement and innovation. Provide training and coaching to enhance technical capabilities and manage team performance.
• Process Standardization and Improvement: Enhance productivity and process effectiveness through lean methodologies. Standardize certification processes to ensure consistency and compliance across operations.
• Cross‑Functional Collaboration: Build and influence a network of contacts within and outside AstraZeneca. Collaborate with IT and QC Network to deliver integrated systems and support a paperless lab environment.
• Project and Change Management: Lead or contribute to local, cross‑functional, or global initiatives. Influence decision‑making, find opportunities for change, and drive efficiency savings.
• Regulatory and Compliance Support: Support regulatory inspections and ensure compliance with industry standards. Maintain expert knowledge of analytical processes and quality systems.
• Risk and Performance Management: Establish metrics to track certification process efficiency and manage risks using evaluative judgment in complex situations.

Essential Skills/Experience

• In‑depth knowledge of compliance management, GMP/GLP principles, and cGMPs.
• Familiarity with Quality Systems (including EQV, Change Controls) and pharmaceutical supply chain standards like Pharmacopeia.
• Exceptional oral and written communication abilities.
• Understanding of Lean processes and demonstrated experience in leading cross‑functional improvement initiatives.
• Thorough understanding of the quality function and its integration with other business functions to achieve organizational objectives.
• Strong problem‑solving, negotiating, and influencing skills with the ability to work independently and take the initiative.
• Proven project management experience, managing global projects and initiatives.
• Willingness to travel nationally and internationally up to 10% of the time.

Desirable Skills/Experience

• Experience working in a PCO/PET organization or Lean/Six Sigma training.
• Multi‑site / multi‑functional experience.
• Proven experience in Quality assurance or combination of Quality and Technical.