Senior Manager – Quality Management System

About the role

The Senior Manager – Quality Management System will lead the design, implementation and continuous improvement of a compliant QMS across the organization. This role ensures that all quality, regulatory and audit activities support timely, accurate decision‑making and sustain product integrity.

Key responsibilities

• Establish and maintain a QMS compliant with ISO 9001 and relevant regional regulations (GCC, EU, USA, WHO).
• Manage internal and external audits, CAPA, documentation, change control, deviations, customer complaints and recall programs.
• Lead the development, certification and ongoing improvement of QMS processes, including KPI design and reporting.
• Oversee the QMS & Documentation team, ensuring GMP change coverage and digitalisation initiatives.
• Prepare, support and follow‑up on regulatory agency inspections and customer audits.
• Drive recall and complaint handling to closure, and resolve escalations related to batch printing and regulatory commitments.
• Provide strategic guidance on data integrity, change‑control assessments and continuous improvement projects.

Required profile

• Bachelor’s or Master’s degree in Pharmaceutical/Life Sciences or Engineering.
• Minimum 10 years of experience in the pharmaceutical industry, with at least 7 years in management roles.
• At least 5 years of experience in paper and electronic data integrity.
• Proven track record in QMS implementation, KPI development and cross‑functional leadership.
• Strong regulatory knowledge across multiple markets and experience leading quality improvement and cost‑saving projects.

Required skills

• ISO 9001 implementation
• Quality Management System (QMS) design and maintenance
• CAPA management
• Internal and regulatory audit execution
• Documentation and change‑control processes
• Data integrity (paper & electronic)
• Recall and complaint handling
• Regulatory knowledge (GCC, EU, USA, WHO)
• KPI design and reporting