QA Manager

About This Role

Lead the Quality Assurance function for a greenfield pharmaceutical facility. Establish QMS, oversee validation, manage deviations/CAPA, and ensure GMP readiness for regulatory inspections.

Key Responsibilities

• Build and lead QA department from ground up
• Develop and implement Quality Management System
• Oversee vendor qualification and audit program
• Manage deviation, CAPA, change control systems
• Lead GMP inspection readiness (MOHAP, GCC, FDA)
• Drive Continuous Improvement (Lean/Six Sigma)
• Collaborate with Regulatory Affairs on submissions

Requirements

• BSc/MSc in Pharmacy, Chemistry, or Life Sciences
• 8+ years pharma QA experience (3+ in leadership)
• EU GMP / PIC/S / FDA inspection experience
• QMS implementation (MasterControl or eQMS) preferred
• Strong knowledge of ICH Q7/Q9/Q10
• Excellent communication and leadership skills