The role is accountable for end-to-end analytical science and QC laboratory quality systems governance to ensure robust execution and inspection readiness
Job Summary
The role is accountable for end-to-end analytical science and QC laboratory quality systems governance to ensure robust execution and inspection readiness.
The incumbent must own core laboratory systems including LIMS, GLIMS, and Empower while maintaining strict data integrity controls under cGMP regulations.
This position requires leading analytical method transfers, managing complex investigations, and partnering with manufacturing teams to deliver compliant API production outcomes.
Matching Summary
The role is accountable for end-to-end analytical science and QC laboratory quality systems governance to ensure robust execution and inspection readiness.
Skills & Requirements
Must-have
Analytical Science & Technology leadership
QC Quality Systems governance
Data Integrity compliance (ALCOA+)
LIMS/GLIMS and Empower system ownership
API manufacturing experience
ICH guidance and cGMP knowledge
Method lifecycle management
Nice-to-have
Lean Six Sigma continuous improvement
Digital transformation initiatives
Global analytical function partnership
Right First Time operational excellence
Strong coaching and people leadership
Key Requirements
Bachelor or Master or Ph.D. in Chemistry or Life Sciences