Quality Manager

Confidential Company

Job Purpose

The Quality Manager is responsible for establishing, implementing, and maintaining an effective Quality Management System (QMS) to ensure full compliance with UAE regulatory authorities (MOHAP, DHA, DOH) and Good Distribution Practice (GDP) guidelines. The role ensures that all pharmaceutical distribution activities meet regulatory, quality, and safety requirements.

Key Responsibilities

Quality Management System (QMS)

• Develop, implement, and maintain the Quality Management System in compliance with GDP, ISO 9001, and UAE regulatory requirements.

• Ensure all quality policies, procedures, SOPs, and records are current, controlled, and approved.

• Lead continuous improvement initiatives across quality processes.

Regulatory Compliance

• Ensure compliance with MOHAP, DHA, DOH, and other relevant UAE health authorities.

• Prepare, manage, and support regulatory inspections and audits.

• Act as the primary point of contact with regulatory authorities for quality-related matters.

GDP Compliance

• Ensure full compliance with WHO / EU GDP guidelines for pharmaceutical storage, handling, and distribution.

• Monitor temperature-controlled storage and transportation (cold chain management).

• Approve and manage deviations, change controls, and risk assessments.

Documentation & Records

• Review and approve SOPs, quality manuals, validation documents, and quality records.

• Ensure proper documentation control and archival in accordance with regulatory requirements.

• Oversee batch documentation, recalls, and complaint handling processes.

Training & Competency

• Develop and manage a GDP training program for all relevant staff.

• Ensure staff competency through training, assessments, and retraining programs.

• Maintain training records and evaluate training effectiveness.

Audits & Inspections

• Plan and conduct internal audits and supplier audits.

• Manage audit findings, CAPAs, and follow-up activities.

• Support customer and regulatory audits.

Risk Management & CAPA

• Lead investigations for deviations, non-conformances, complaints, and OOS/OOT issues.

• Implement Corrective and Preventive Actions (CAPA).

• Perform quality risk management using tools such as FMEA or risk assessments.

Supplier & Contractor Qualification

• Qualify and monitor suppliers, logistics providers, and service contractors.

• Conduct quality agreements and supplier performance evaluations.

• Ensure outsourced activities meet GDP and regulatory requirements.

Product Recall & Pharmacovigilance Support

• Establish and manage product recall procedures.

• Coordinate mock recalls and ensure traceability.

• Support pharmacovigilance activities as required by UAE regulations.