SFDA Technical Manager

The SFDA Technical Manager - KSA is responsible for ensuring full compliance with SFDA regulatory requirements across pharmaceutical GMP manufacturing in line with SFDA requirements
, quality systems, and product release processes.

Engaged on a 1-year consultancy basis
, this role provides technical oversight and regulatory assurance for GMP compliance, batch release, and quality governance aligned with SFDA standards. The incumbent acts as the primary technical authority interfacing with regulatory bodies, ensuring that all processes, documentation, and manufacturing practices meet required standards.

This role is primarily advisory and oversight focused, providing technical guidance, compliance review, and regulatory support rather than full time operational management of manufacturing activities.

• Ensure full compliance with SFDA regulations, GMP standards, and pharmaceutical guidelines.
• Act as the technical focal point for SFDA related matters, inspections, and audits.
• Provide independent technical oversight and regulatory advisory support to ensure ongoing compliance with SFDA pharmaceutical manufacturing standards.
• Ensure all documentation aligns with SFDA expectations and audit readiness standards.

• Oversee implementation and adherence to Pharmaceutical Good Manufacturing Practices (GMP) in line with SFDA requirements.
• Review and strengthen quality systems to ensure compliance with regulatory standards.
• Ensure proper documentation, validation, and traceability across production processes.
• Support continuous improvement of quality assurance frameworks.

• Ensure batch release processes comply with SFDA requirements.
• Review batch records, quality documentation, and release approvals.
• Ensure product quality, safety, and compliance before market release.
• Support investigation and resolution of quality deviations.

• Provide technical support to QA/QC and manufacturing teams.
• Ensure alignment between production practices and regulatory standards.
• Support root cause analysis for quality issues and corrective actions.
• Ensure compliance across all stages of the manufacturing lifecycle.

• Prepare the organization for SFDA inspections and external audits.
• Lead internal audit reviews and compliance gap assessments.
• Ensure timely closure of audit findings and regulatory observations.
• Maintain full readiness for regulatory reviews at all times.

• Zero critical SFDA non compliance findings
• 100% audit readiness at all times
• Timely closure of regulatory observations

• Full adherence to GMP standards
• Reduction in quality deviations
• Effective implementation of corrective actions

• 100% compliant batch release
• Zero product recall due to compliance issues
• Accuracy and completeness of batch documentation

• Timely regulatory support to manufacturing teams
• Effective resolution of quality related issues
• Alignment between QA/QC and production processes

• Operates under broad direction with full accountability for regulatory compliance.
• Exercises judgment in technical and quality related decisions.

• Influences QA/QC, Manufacturing, and leadership teams on compliance requirements.
• Acts as a key liaison with regulatory authorities (SFDA).

• Manages complex regulatory requirements and manufacturing compliance standards.
• Balances operational needs with strict regulatory expectations.

• Demonstrates strong regulatory knowledge and technical expertise.
• Applies analytical thinking to quality and compliance challenges.
• Ensures alignment between regulatory compliance and business operations.

• Education: Bachelor's degree in Pharmacy (mandatory).
• Licensing: Licensed Pharmacist registered with the Saudi Commission for Health Specialties (SCFHS).
• Experience: Minimum 3 years of experience in pharmaceutical manufacturing, quality, or regulatory roles.
• Saudi nationality is preferred due to regulatory and licensing considerations.

• Strong knowledge of SFDA GMP requirements and regulatory compliance
• Experience in QA/QC and pharmaceutical manufacturing processes
• Expertise in batch release and quality documentation
• Understanding of audit and inspection processes
• Strong analytical and problem solving capabilities
• Ability to work in a regulated and compliance driven environment

• Internal: Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Supply Chain
• External: SFDA, Auditors, Regulatory Consultants, Compliance Authorities