Job description

The Manager – Technical in pharmaceutical manufacturing is responsible for leading all technical and quality-related functions across plant operations in full compliance with Saudi Food and Drug Authority (SFDA) requirements and global pharmaceutical regulatory standards. The role ensures the implementation, oversight, and continuous improvement of the Quality Management System (QMS) within a cGMP-regulated environment, covering all aspects of pharmaceutical production, quality assurance, and regulatory compliance. The position is accountable for final approval of suppliers for raw materials, semi-finished goods, and packaging materials, as well as technical agreements related to outsourced manufacturing activities. It also oversees approval of changes related to facilities, utilities, production lines, and product variations to ensure compliance with validated processes and regulatory requirements. The Manager – Technical is responsible for reviewing and approving critical quality documentation such as Site Master Files, Quality Manuals, Validation Master Plans, process validation protocols, equipment qualification documentation, and change control records. The role ensures proper handling of deviations, OOS investigations, product complaints, and recall processes, including root cause analysis and implementation of corrective and preventive actions (CAPA). It ensures full adherence to SFDA, FDA, WHO, EU, ISO 9001, and ISO 14001 standards, including compliance with controlled and narcotic substance regulations under Saudi law. The position also represents the manufacturing site during regulatory inspections and ensures accurate preparation and submission of technical documentation for product registration and renewals. From an operational standpoint, the role ensures successful execution of technology transfer activities and product lifecycle management processes while maintaining audit readiness and regulatory compliance. The Manager – Technical also conducts internal audits and management reviews to assess QMS performance and drive continuous improvement initiatives. Additionally, the role is responsible for leadership and development of technical staff, including defining job roles, setting performance expectations, identifying competency gaps, and implementing training programs. It fosters a culture of quality, accountability, safety, and compliance across all technical functions. The role includes responsibility for environmental, health, and safety (EHS) compliance aligned with ISO 14001:2015, NCOSHA, SASO, OSH, and NEBOSH guidelines, ensuring hazard reporting, risk mitigation, and environmental impact reduction. The position requires strong leadership, analytical thinking, regulatory expertise, and the ability to manage complex technical operations in a highly regulated pharmaceutical environment.