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.
Incumbents must own the analytical method lifecycle including development, validation, and verification while ensuring alignment with ICH guidance and site SOPs.
This position serves as the primary escalation point for audits and inspections involving laboratory systems, data integrity, and analytical practices.
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.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Analytical Science & Technology leadership
QC laboratory quality systems governance
Data Integrity ALCOA+ principles
LIMS and Empower system ownership
API manufacturing environment experience
ICH guidance and cGMP compliance
Nice-to-have
Lean Six Sigma continuous improvement
Digital transformation initiatives
Strong stakeholder partnership skills
Visible GMP presence culture
Sustainable capability building approach
Key Requirements
Bachelor or Master or Ph.D. in Chemistry or Life Sciences
Minimum 8 years pharmaceutical manufacturing or QC experience
Minimum 5 years leadership/supervisory position experience
Governance experience with LIMS/GLIMS and Empower
Extensive knowledge of GMP compliance for QC Laboratories