Senior Internal Auditor

Company Overview

SVAX is a biopharmaceutical company specializing in biologics and biosimilars, located in Jeddah, Saudi Arabia. The company is developing a comprehensive platform encompassing research and development, regulatory affairs, clinical development, and commercial-scale manufacturing. SVAX's growth aligns with Saudi Vision 2030 and the National Biotech Strategy, prompting expansion of its governance, risk management, and compliance frameworks to meet the needs of investors, partners, and regulatory bodies.

Position Summary

This newly established Internal Audit role reports functionally to the Board of Directors and administratively to the Chief Operating Officer. The position is critical in setting up and executing the internal audit charter, methodology, and annual plan to support SVAX's growth into GMP manufacturing, clinical trials, and strategic investment endeavors. The right candidate combines traditional internal audit skills with specific expertise in GxP quality systems, clinical and regulatory compliance, and familiarity with the operating environment of a startup biopharma within Saudi Arabia's regulatory context.

Key Responsibilities

• Develop and formalize the Internal Audit Charter and risk-based audit program for Board approval, aligning with international audit standards and Saudi regulatory requirements.
• Create and maintain internal audit policies, procedures, and standardized reporting consistent with the IIA IPPF framework.
• Establish a comprehensive risk register covering financial, operational, regulatory, clinical, manufacturing, and third-party risks.
• Plan and implement audits of financial controls including revenue, procurement, treasury, payroll, assets, and compliance with grants and loans.
• Evaluate internal controls in accordance with SOCPA standards and company governance demands.
• Conduct audits across procurement, contracts, business development, joint ventures, licensing, and distribution agreements.
• Support reviews related to Zakat, Tax, and Customs Authority compliance.
• Partner with Quality Assurance and Regulatory teams to audit GMP, GCP, and GLP compliance, data integrity, and quality systems preparing for SFDA inspections.
• Assist in inspection readiness for manufacturing licenses, clinical trial conduct, and product registration dossiers.
• Monitor corrective actions from audits, inspections, and quality incidents.
• Contribute to the ERM framework by identifying and escalating risks including clinical, regulatory, financial, cybersecurity, and third-party areas.
• Support governance oversight by participating in Procurement Committee, Board, and NRC activities regarding governance, related-party transactions, and conflicts of interest.
• Lead fraud risk assessments and investigations, liaising with regulatory anti-corruption bodies as necessary.
• Audit third-party manufacturing, licensing, and supplier arrangements for contract, quality, and financial compliance.
• Review controls for joint ventures and partnerships to ensure governance adherence.
• Deliver risk-focused audit reports to the Audit Committee, CEO, and COO with clear remediation plans and tracking.
• Collaborate with external auditors to align efforts and enhance statutory audit processes.
• Foster an organizational culture emphasizing accountability, transparency, and continual enhancement.

Qualifications

• Bachelor's degree in Accounting, Finance, Life Sciences, or a related field is mandatory; a Master's (MBA or MSc) is an advantage.
• Professional certifications such as SOCPA Fellowship, CIA, CISA, or CFE are strongly preferred.
• A minimum of 3 years of progressive internal or external audit experience with at least 3 years in biotech, pharmaceutical, life sciences, or similar regulated/GxP industries.
• Experience in developing or scaling internal audit functions in growth-stage or pre-commercial organizations is highly valued.
• Knowledgeable in GMP, GCP, GLP regulatory standards and quality operational risks.
• Experience engaging in investor due diligence, joint ventures, or licensing is a plus.
• Strong understanding of SFDA regulations, CMA governance rules, and Saudi/GCC regulatory frameworks.
• Excellent analytical, risk evaluation, and communication abilities in both Arabic and English, particularly for executive-level reporting.
• Proficiency with ERP systems, audit software, and data analytics tools such as Excel, Power BI, ACL, or IDEA.
• Capacity to operate independently in a dynamic startup setting while upholding rigorous audit integrity.

Location and Employment

• Position is based in Jeddah, Saudi Arabia, with onsite or hybrid work arrangements as per company policies.
• Employment is full-time.
• Occasional travel may be required to manufacturing, clinical sites, and partner locations.