Quality Assurance Manager

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.

The Quality Assurance Manager leads the site Quality Management System (QMS) and ensures full compliance with GMP, EDA regulations, global quality requirements, and internal corporate standards. The role oversees batch disposition, quality systems governance, validation oversight, documentation control, audits, training, shopfloor compliance, and continuous improvement initiatives. The QA Manager ensures that all manufacturing, packaging, and technical operations activities meet regulatory and quality expectations, while contributing to operational excellence and product quality improvement. The job holder will be based in our site in Cairo, al Obour City and reporting to the Quality Site Head.

Your responsibilities:

Quality Systems Governance

• Review and approve the Site Master File.
• Approve all SOPs for all technical departments, ensuring proper version control, periodic review, and effective implementation.
• Review and approve the Validation Master Plan, validation and qualification protocols, and reports.
• Review and approve internal and external audit reports; ensure timely and effective CAPA closure.
• Approve the Training Plan and Training Matrix, ensuring implementation as per schedule and monitoring training effectiveness.
• Approve and ensure execution of the Self-Inspection Program as per schedule.
• Supervise document control systems, ensuring proper documentation lifecycle, controlled updates, and compliant archiving practices.
• Review Technical Quality Agreements (TQA) as needed.
• Supervise EDA communications and ensure full compliance with GMP and EDA guidelines.

Batch Release & Documentation Control

• Supervise the final release of manufacturing and packaging batch records.
• Evaluate all supporting documents and assure the final disposition decision for product release.
• Approve Master Manufacturing Records (MMR) and Master Packaging Records (MPR).
• Approve specifications for raw materials, packaging materials, and finished products.
• Ensure accuracy and completeness in shopfloor batch record reviews prior to release.

Equipment, Facilities & Utilities Oversight

• Review and approve the Annual Preventive Maintenance Plan and the Calibration Plan.
• Monitor the implementation of calibration, preventive maintenance, and environmental monitoring programs.
• Ensure full GMP compliance across facility, equipment, and utilities.

Quality Risk & Compliance Management

• Review and approve deviations, change control requests, complaints, recall evaluations, and risk assessment reports.
• Ensure strong CAPA effectiveness and timely implementation across systems.
• Lead, participate in, and support internal/external audits and regulatory inspections.
• Facilitate and oversee investigations for deviations, complaints, and product quality issues; prepare reports to global teams as required.

Shopfloor Quality Oversight

• Supervise QA presence and activities across all Technical Operations departments.
• Ensure continuous shopfloor monitoring through routine inspections and quality tours.
• Ensure implementation of the latest cGMP standards across all manufacturing areas.
• Ensure immediate escalation and management of any identified nonconformities.

Validation, Performance & Continuous Improvement

• Validate quality processes by establishing and approving specifications, documentation requirements, and qualification approaches.
• Review and approve the Annual Product Quality Review (APQR).
• Drive and support continuous improvement initiatives related to quality, productivity, and compliance.
• Contribute to strategic planning, action-plan development, and system enhancements.

Artwork & Regulatory Documentation

• Oversee and monitor the full artwork lifecycle, ensuring accuracy, consistency, and alignment with regulatory requirements.

People Development & Knowledge Management

• Support compliance with training requirements and competency development for QA teams and technical departments.
• Maintain up-to-date knowledge of global trends and developments in Quality Management and GMP.
• Promote a culture of quality, ownership, accountability, and continuous learning.

Qualification and Experience:

• Bachelor's degree in Pharmacy, Science, or related field.
• Minimum 10 years in Quality Assurance within pharmaceutical manufacturing.
• Strong knowledge of GMP, EDA regulations, validation, and pharmaceutical quality systems.
• Leadership skills and experience managing quality teams.
• Excellent problem‑solving, documentation, and audit capabilities.

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!