SFDA Technical Manager

Overview

SFDA Technical Manager – KSA

Regulatory Compliance & SFDA Oversight

• 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.

GMP & Quality Systems Management

• 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.

Batch Release & Product Compliance

• 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.

Quality Assurance & Manufacturing Support

• 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.

Audit & Inspection Readiness

• 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.

Compliance & Governance

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

Quality & GMP Performance

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

Batch Release & Product Quality

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

Operational Support

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

Autonomy

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

Influence

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

Complexity

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

Business Skills

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

Education & Experience

• **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.

Qualifications

• 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

Key Relationships

• **Internal:**
• Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Supply Chain
• **External:**