Senior Manager – Quality Management System

About the role

We are seeking a Senior Manager to lead and continuously improve our Quality Management System (QMS) within a pharmaceutical environment. The role ensures compliance with ISO 9001, regulatory requirements, and internal standards while supporting data integrity and product safety.

Key responsibilities

• Establish and maintain a compliant QMS, including ISO 9001 certification.
• Manage internal and external regulatory audits, CAPA, documentation/change control, deviations, customer complaints, and recall programs.
• Redesign and streamline procedures to meet industry and regulatory standards.
• Lead the QMS & Documentation team, providing guidance on GMP changes and digitalization initiatives.
• Prepare, execute, and support external regulatory inspections and customer audits.
• Develop and present QMS metrics, KPI dashboards, and performance reports.
• Oversee recall and complaint functions, ensuring timely closure and root‑cause analysis.
• Drive continuous improvement, innovation, and compliance across all quality processes.

Required profile

• Bachelor’s or Master’s degree in Pharmaceutical/Life Sciences or Engineering.
• Minimum 10 years of experience in the pharmaceutical sector, with at least 7 years in a management role.
• At least 5 years of experience in paper and electronic data integrity.
• Proven track record in system initiation, KPI design, and cross‑functional collaboration.
• Strong regulatory knowledge for GCC, EU, USA, and WHO markets.
• Demonstrated ability to lead quality improvement projects and manage crises.

Required skills

• ISO 9001 implementation and certification.
• Quality Management System (QMS) administration.
• CAPA management.
• Internal and regulatory audit execution.
• Documentation and change‑control processes.
• Data integrity (paper & electronic).
• Recall and complaint handling.
• KPI design and performance monitoring.