Senior Specialist, Quality System, QA

AstraZeneca · Su Zhou Shi, Jiang Su Sheng, China

Location

Su Zhou Shi

Job Type

Full-time

Posted

June 11, 2026

Job Description

Major responsibilities 
Global Alignment & Harmonization: Map site procedures to corporate/global SOPs, harmonize terminology and process flows, and drive adoption of global standards, templates, and metrics. Lead gap assessments and remediation to ensure full integration and consistency.
Implement ECMS at Suzhou site: Work with global project team to promptly execute global ECMS implementation and project timeline at Suzhou site as local representative.
Clinical Lifecycle Readiness: Ensure controls support tech transfer from development to GMP clinical supply, scale‑out/scale‑up, protocol amendments, and eventual commercial transition.
Document Control: Establish controlled lifecycle management for SOPs, policies, work instructions, forms, and templates; ensure controlled issuance, versioning, approval, periodic review, and archival in the electronic system.
Data Integrity: Implement ALCOA/ALCOA+ principles for paper and electronic procedures ...
        

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