Drive adoption of global quality standards, templates, and metrics, leading gap assessments and remediation for full integration and consistency
Job Summary
Drive adoption of global quality standards, templates, and metrics, leading gap assessments and remediation for full integration and consistency.
Ensure quality controls support the clinical lifecycle from development to commercial transition, including document control and data integrity principles.
Actively monitor quality performance indicators, provide routine reports to leadership, and participate in continuous improvement initiatives.
Matching Summary
Drive adoption of global quality standards, templates, and metrics, leading gap assessments and remediation for full integration and consistency.
Skills & Requirements
Must-have
Global Alignment & Harmonization
ECMS implementation at Suzhou site
Document Control lifecycle management
Data Integrity ALCOA/ALCOA+ principles
Role-based GMP training matrices
Quality Performance monitoring and reporting
Nice-to-have
Cross-functional collaboration and prioritization
Continuous improvement initiatives
Strong ownership and self-motivation
Rigorous logical thinking
Key Requirements
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
5+ years of experience in robust GMP quality system