Audit Readiness Section Head

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

As Audit Readiness Section Head, you will be responsible for quality oversight activities to ensure GMP compliance across manufacturing, facilities, utilities, and warehouse operations. Conducts GMP walk-throughs, supports investigations, deviations, CAPAs, and QMS improvements, including SOP reviews and gap assessments. Performs quality impact assessments, supports root cause analysis, promotes data integrity, and mentors team members on GMP and documentation practices while ensuring effective implementation of quality actions and continuous compliance.

Job Holder will be reporting to Quality Compliance Manager and will be located in our site at El-Obour City.

Key Responsibilities:

• Conduct routine GMP walk-throughs across manufacturing, warehouse, facilities, and utilities to identify compliance gaps and support adherence to regulatory and internal standards
• Perform regular Gemba activities in GxP areas to ensure operations are executed in line with GMP and Good Documentation Practices (GDP)
• Support quality oversight by monitoring departmental activities and highlighting compliance risks in alignment with company policies, GMP, EDA, and ISO requirements
• Participate in real-time investigations of deviations and non-conformances to ensure proper classification, thorough investigation, and timely resolution
• Contribute to root cause analysis (RCA) and support the identification of effective corrective and preventive actions (CAPAs)
• Review CAPA responses, follow up on implementation, and support tracking to ensure effectiveness and closure within defined timelines
• Provide timely quality impact assessments for deviations and issues with potential impact on product quality
• Support trending analysis of deviations and non-conformances to identify recurring issues and improvement opportunities
• Participate in investigations related to manufacturing, facilities, utilities, and environmental monitoring, and support preparation and review of investigation reports
• Contribute to the effectiveness of the Quality Management System (QMS) by participating in gap analyses and supporting continuous improvement initiatives
• Review and update SOPs and support the development of QA procedures in alignment with regulatory expectations
• Promote data integrity and quality culture initiatives within the organization
• Demonstrate and advocate Good Documentation Practices (GDP) across all functions
• Support training activities by ensuring compliance with training requirements and contributing to the effectiveness of learning programs for shift personnel
• Provide guidance, coaching, and knowledge sharing to colleagues on GMP principles and quality best practices
• Support the management of quality-related events within Quality Operations, ensuring appropriate documentation, follow-up, and closure

Desired Candidate Profile

• Bachelor's degree in pharmacy, Science, or a related field
• 7-10 years of experience in Quality Assurance within a pharmaceutical or regulated manufacturing environment
• Strong knowledge of GMP, GDP, and regulatory requirements (e.g., EDA, ISO standards)
• Experience in deviation management, investigations, CAPA, and QMS processes
• Familiarity with manufacturing, utilities, and facility operations in a GxP environment
• Experience in SOP review, documentation, and audit readiness activities
• Good understanding of data integrity and quality risk management principles

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!