【AstraZeneca】【JOPS】Associate Quality Director,External Quality
Core
Oversees quality management of external suppliers within the Procurement Quality AsiaPac teams, ensuring compliance with quality systems and managing supplier performance.
Role type
Associate Quality Director (External Quality)
Builds
Quality Agreements, supplier quality assessments, and regulatory inspection readiness for external suppliers.
Domain
Pharmaceutical supply chain and quality assurance
Required skills
cGMP knowledge, Quality Systems expertise, Pharmaceutical supply chain understanding, ISO standards knowledge, Change control management, Product quality complaint handling, S&L complaint investigation, Deviation investigations, Quality issue management, Quality Agreement establishment, Regulatory Agency interaction, Supplier Quality Assessments, Project management, Cross-functional collaboration, Problem solving, Negotiation, Influencing
Preferred skills
PCO/PET organization experience, Lean/Six Sigma training, Multi-site experience, Quality Assurance experience, Masters Degree in Quality Assurance/Regulatory Affairs
Technologies
cGMP, ISO standards, Pharmacopeia
Responsibilities
Oversee quality system(s) for assigned external suppliers, manage change control and deviation investigations, prepare and submit periodic Supplier Quality Assessments, manage Regulatory Agency interactions and inspections, lead quality on new supplier introductions and process optimization projects.
Seniority
Senior, hands-on IC