Methodology & Stability Manager

About the role

The Methodology & Stability Manager will lead the laboratory’s compliance with cGMP and GLP standards, ensuring that all processes, equipment and documentation meet regulatory requirements. This senior position oversees stability testing, method validation and the preparation of registration dossiers for the Egyptian and Saudi markets.

Key responsibilities

• Maintain laboratory processes in strict accordance with cGMP and GLP guidelines.
• Plan, execute and document calibration and validation of all departmental equipment.
• Develop, review and update Standard Operating Procedures to reflect current best practices.
• Implement Health & Safety and other legal requirements across the lab.
• Approve stability protocols, reports and related records.
• Prepare stability files for new products and re‑registration projects.
• Ensure timely and accurate submission of eCTD registration documents for Egypt and KSA.
• Train and supervise staff to perform their tasks competently.

Required profile

• Bachelor’s degree in Pharmaceutical Science.
• 10+ years of experience in a similar role within the pharmaceutical industry.
• Strong knowledge of GMP, GLP, stability testing and analytical method validation.
• Proven experience in documentation, internal auditing and staff training.
• Demonstrated leadership and managerial abilities.

Required skills

• cGMP compliance
• GLP compliance
• Stability testing
• Analytical method validation
• Documentation and record‑keeping
• Internal auditing
• Microsoft Office proficiency