QA Compliance Manager

About the role

Arcera, a global life sciences company headquartered in Abu Dhabi, is looking for a QA Compliance Manager based in Cairo. The role supports the Arcera Corporate Quality function, focusing on maintaining internal and external audit processes, including the annual audit programme, inspection management, recall and escalation management, and global process ownership of the dossier compliance check.

Key responsibilities

• Plan quality audit activities across the Arcera network, including establishing and updating the Global Annual Quality Audit plan
• Identify risk areas and give independent assessments of the impact of audited activities
• Support the development of a global risk-based audit strategy and monitor the annual external/internal and inspection/customer audit plans
• Maintain up-to-date knowledge of regulations, standards and guidance documents
• Act as global process owner for regulatory compliance checks, including ownership of the procedures
• Lead Global Escalation Management and support the Inspection Readiness programme at Arcera sites and offices
• Support maintenance and improvement of computerised Quality Audit and Supplier Management tools
• Establish and maintain global SOPs under GxP audits and compliance, and support corporate internal audits when needed
• Guide site, local and regional QA teams on GxP topics and provide GxP training

Required profile

• Bachelor's or master's degree in pharmacy, chemistry, biology, engineering or another related science
• At least 10 years of QA experience in the pharmaceutical industry, preferably including GxP auditing experience
• Excellent oral and written communication skills in business English
• Ability to overcome cultural and language differences to meet corporate, regional and local objectives
• Self-motivated, flexible, responsible and eager to learn

Required skills

• Knowledge of EU, PIC/S, WHO and other relevant GxP guidelines and regulations
• Knowledge of ISO 9001, ISO 13485, ISO 22716 and ISO 22000 is a plus
• General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology

Candidates apply directly through the company's HR system; only direct applications will be considered.