Job Scope
- Lead and develop QC teams (5–7 direct)
- Oversee daily laboratory operations, including analytical testing and equipment systems
- Ensure compliance with GLP, GDP, cGMP, and internal quality standards
- Manage QC quality systems, audits, and regulatory requirements
- Drive analytical method transfer, validation, and stability programs
- Partner with cross-functional teams (e.g., Production, Supply Chain)
- Lead continuous improvement initiatives (Lean, Six Sigma, SPC, RFT)
- Manage laboratory budget and CAPEX planning
- Ensure EHS compliance and promote a safety culture
- Support regulatory reporting and uphold quality and compliance standards
Requirements
- Degree in Chemistry, Pharmaceutical Sciences, Microbiology, or related field
- 8–10+ years of QC experience in pharma or related industries
- At least 5 years of leadership experience managing teams
- With expertise in:
- Analytical chemistry and method validation
- Laboratory systems (e.g., LIMS, HPLC, GC, Empower)
- cGMP, GLP, and data integrity