Associate Director, Quality
AstraZeneca
Associate Director Quality role overseeing supplier quality management across formulation, fill-finish, and packaging operations. Responsibilities include conducting supplier assessments, managing quality systems, reviewing regulatory documentation, and ensuring GMP compliance throughout the external supply chain.
Responsibilities
- Lead supplier quality management including annual assessments, agreements, and quality system reviews
- Review and approve cGMP documentation for suppliers including change requests and product quality reviews
- Manage quality issue escalation and resolution to ensure compliant product delivery
- Support regulatory agency inspections and participate in GMP compliance auditing processes
- Collaborate across teams to drive continuous improvement and ensure regulatory implementation strategies
Requirements
- Bachelor's degree in science or technical field (Pharmacy, Biology, Chemistry, Engineering)
- 10+ years experience in pharmaceutical Quality Assurance or operations
- Strong knowledge of cGMP, quality systems, and pharmaceutical supply chain
- Demonstrated cross-functional project management and process improvement experience
- Strong written and oral communication skills in English and local language(s)
- Excellent problem-solving and negotiating/influencing capabilities
- Willingness to travel nationally and internationally up to 25% annually
Vacancy posted 6 days ago
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