SFDA Technical Manager

About the role

The SFDA Technical Manager (KSA) is engaged on a 1‑year consultancy basis to provide technical oversight and regulatory assurance for pharmaceutical GMP manufacturing. The incumbent acts as the primary technical authority, ensuring that all processes, documentation, and manufacturing practices meet SFDA standards.

Key responsibilities

• Ensure full compliance with SFDA regulations, GMP standards, and pharmaceutical guidelines.
• Act as the technical focal point for SFDA inspections, audits, and regulatory matters.
• Oversee implementation and adherence to GMP practices and strengthen quality systems.
• Review batch records, quality documentation, and approve batch releases in line with SFDA requirements.
• Provide technical support to QA/QC and manufacturing teams, including root‑cause analysis and corrective actions.
• Prepare the organization for SFDA inspections, lead internal audits, and ensure timely closure of audit findings.

Required profile

• Proven experience in pharmaceutical GMP manufacturing and regulatory compliance.
• Strong knowledge of SFDA regulatory requirements and inspection processes.
• Ability to provide independent technical oversight and advisory support.
• Excellent documentation and audit‑readiness skills.

Required skills

• SFDA regulatory compliance
• Good Manufacturing Practices (GMP)
• Pharmaceutical batch release processes
• Quality systems management
• Audit and inspection readiness