Responsibilities:
Supervise daily lab operations, advanced analytical testing, and equipment systems. Ensure compliance with GLP, GDP, cGMP, and company standards. Oversee QC quality systems, regulatory readiness, and internal/external audits. Direct and mentor a robust QC team, managing a team up to 40 members. Serve as the QC subject matter expert for production, supply chain, and other key departments. Lead Analytical Method Transfer (AMTE) and validation projects. Cultivate a culture of operational excellence using Lean/Six Sigma, Right First Time (RFT), and Statistical Process Control (SPC). Drive fiscal responsibility through laboratory budgeting and CAPEX planning. Foster a proactive EHS culture to ensure a safe workplace. Oversee stability programs and regulatory reporting while acting as a champion for an uncompromising quality culture.
Requirements: Bachelor's degree or higher in Chemistry, Pharmaceutical Sciences, Microbiology, or a related scientific discipline. 8–10+...