Head Quality

Role & responsibilities

• Lead QA, QC & Microbiology functions and define overall Quality strategy.
• Establish and continuously improve QMS, SOPs, CAPA, Change Control, Deviations, OOS/OOT, Risk Management and Document Control.
• Ensure GMP compliance across manufacturing, packaging, warehousing and distribution.
• Oversee batch documentation, product disposition and batch release.
• Lead QC laboratory activities, analytical testing, investigations and equipment qualification/calibration.
• Drive Microbiology, environmental monitoring and contamination-control programs.
• Lead regulatory inspections and customer audits including exposure to USFDA, EU and CE/MDR requirements.
• Oversee validation & qualification of facility, equipment, utilities, processes, cleaning, analytical methods and computerized systems.
• Manage customer complaints, recalls, PMS and quality risk management.
• Lead supplier qualification, vendor audits, Quality Agreements and supplier CAPA.
• Provide Quality support for NPD, technology transfer, process validation and commercialization.
• Drive Quality improvement, Right-First-Time, Lean Quality and reduction of deviations, CAPA, complaints and OOS.
• Build and develop a strong QA, QC & Microbiology team and succession pipeline.

Preferred candidate profile

• 15+ years of progressive Quality experience in Pharma, Medical Devices, Infection Prevention, Disinfectants, Healthcare or other regulated industries.
• Strong leadership experience across QA/QC/Microbiology.
• Strong knowledge of Global GMP, QMS and international regulatory requirements.
• Experience in USFDA / EU / CE-MDR / customer audits preferred.
• Strong expertise in CAPA, Change Control, OOS/OOT, QRM, Validation, Data Integrity and Audit Management.
• Experience managing multidisciplinary Quality teams in a manufacturing environment.