Senior Manager - Quality MSAT

About the role

Julphar is looking for a Senior Manager - Quality MSAT in Ras Al Khaimah. The role leads equipment, facilities and utilities qualification, computerized system validation, calibration and quality management, ensuring compliance with GMP and regulatory requirements.

Key responsibilities

• Lead the qualification lifecycle of equipment, facilities and utilities using the V-Model, from URS and technical evaluation through FAT, SAT, IQ, OQ, PQ and periodic requalification
• Keep critical utilities such as Purified Water, Water for Injection, compressed air and nitrogen qualified and compliant
• Oversee cleanroom qualification under ISO 14644
• Validate computerized systems for Quality Control, Manufacturing and Utilities, including 21 CFR Part 11 compliance, and maintain them with data integrity
• Manage instrument and equipment calibration, keeping schedules up to date and addressing deviations
• Lead Validation SMEs, provide technical guidance and support team capability development
• Support Change Controls, Deviation Investigations, CAPA and audits through the Electronic Quality Management System (EQMS)
• Coordinate with cross-functional teams on product lifecycle and country-specific regulatory and registration requirements
• Manage, archive and distribute validation and qualification documentation
• Lead quality improvement and risk management initiatives and apply data integrity principles (ALCOA+)
• Comply with the Environmental Management System (ISO 14001:2015), EHS policies and workplace safety requirements

Required profile

• Bachelor's degree in Engineering, Science or Pharmacy
• At least 10 years of experience in equipment qualification, utilities qualification, calibration and validation in pharmaceutical or regulated manufacturing
• Knowledge of GMP, GDP, ISO 9001 and ISO 14001, and of FDA, WHO and EU regulations
• Experience in CSV, qualification lifecycle management, calibration systems, EQMS, audits, CAPA and risk management
• Leadership experience managing technical teams and coordinating cross-functional work

Required skills

• Computerized system validation and calibration systems
• Electronic Quality Management Systems (EQMS)
• Microsoft Office