Senior Internal Auditor
svax- Posted 2 hours ago
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Job Description
Company Overview
SVAX is a biologics and biosimilars biopharmaceutical company based in Jeddah, Saudi Arabia, building a fully integrated biopharmaceutical platform spanning R&D, regulatory affairs, clinical development, and commercial-scale manufacturing. Aligned with Saudi Vision 2030 and the National Biotech Strategy, SVAX is scaling its organizational infrastructure to meet the governance, risk, and compliance expectations of institutional investors, strategic partners, and regulatory authorities as it expands its commercial operations.
Position Summary
SVAX is establishing an Internal Audit function as a newly created role, reporting functionally to the Board of Directors and administratively to the Chief Operating Officer. This is a foundational, high-visibility position responsible for designing and operationalizing SVAX's internal audit charter, methodology, and annual audit plan from the ground up, appropriate to a growth-stage biotech scaling toward GMP manufacturing, clinical trial execution, and institutional/strategic investment (e.g., equity partners, joint ventures, and licensing agreements).
The successful candidate will bring a blend of traditional internal audit rigor (financial controls, corporate governance, risk management) with sector-specific fluency in GxP quality systems, clinical and regulatory compliance, and the operational realities of a startup biopharma organization operating within the Kingdom's regulatory framework.
Key Responsibilities
1. Audit Function Design & Governance
• Draft and formalize the Internal Audit Charter, methodology, and risk-based annual audit plan for Board Audit Committee approval.
• Establish internal audit policies, procedures, and reporting templates consistent with the Institute of Internal Auditors (IIA) International Professional Practices Framework (IPPF).
• Align the function with the CMA's Corporate Governance Regulations and applicable Ministry of Commerce requirements for joint-stock/closed companies.
• Build a company-wide risk register/risk universe covering financial, operational, regulatory, clinical, manufacturing, and third-party/vendor risk.
2. Financial & Operational Audits
• Plan and execute financial control audits (revenue recognition, procurement-to-pay, treasury, payroll, fixed assets, grant/loan compliance) to safeguard assets and ensure the integrity of financial reporting.
• Evaluate the design and operating effectiveness of internal controls over financial reporting, in line with SOCPA (Saudi Organization for Chartered and Professional Accountants) standards and good governance practice appropriate to the company's growth stage.
• Conduct operational audits across procurement, contracting, and business development activities, including joint ventures, licensing, and distribution agreements.
• Support compliance with Zakat, Tax and Customs Authority (ZATCA) obligations relevant to internal control review.
3. GxP, Quality & Regulatory Compliance Audits
• Partner with Quality Assurance and Regulatory Affairs to conduct internal audits of GMP, GCP, and GLP compliance, data integrity, and quality management systems (QMS) ahead of SFDA inspections.
• Support inspection-readiness assessments for manufacturing facility licensure, clinical trial conduct, and product registration/dossier submissions.
• Monitor closure of CAPAs (Corrective and Preventive Actions) arising from internal audits, regulatory inspections, and quality deviations.
4. Risk Management & Corporate Governance
• Serve as a key contributor to the enterprise risk management (ERM) framework, identifying and escalating emerging risks (clinical, regulatory, financial, cybersecurity, third-party).
• Support the Procurement Committee, Board, and NRC with independent assurance over governance processes, related-party transactions, and conflict-of-interest matters.
• Lead or coordinate fraud risk assessments and, where required, internal investigations, in coordination with the National Anti-Corruption Commission (Nazaha) reporting obligations where applicable.
5. Third-Party & Vendor Audits
• Audit CDMO/CMO relationships, licensing partners, and critical suppliers for contractual, quality, and financial compliance.
• Assess controls within joint ventures and strategic partnerships for adherence to agreed governance and reporting obligations.
6. Reporting & Continuous Improvement
• Prepare clear, risk-prioritized audit reports and present findings to the Audit Committee, CEO, and COO, with actionable remediation plans and follow-up tracking.
• Liaise with external auditors to align scope, avoid duplication, and support statutory audit and due diligence processes (including investor/board-level due diligence).
• Champion a culture of accountability, transparency, and continuous improvement across the organization.
Qualifications
Education
• Bachelor's degree in Accounting, Finance, Life Sciences, or a related field (required).
• Master's degree (MBA, MSc) is a plus.
Certifications (one or more strongly preferred)
• SOCPA Fellowship / Saudi CPA
• Certified Internal Auditor (CIA)
• Certified Information Systems Auditor (CISA)
• Certified Fraud Examiner (CFE)
Experience
• 3–7 years of progressive internal audit, external audit (Big 4 or equivalent), or compliance experience, with at least 3 years in a biotech, pharmaceutical, life sciences, or other regulated/GxP industry.
• Demonstrated experience building or scaling an internal audit function within a growth-stage or pre-commercial organization is highly valued.
• Working knowledge of GMP, GCP, and/or GLP regulatory frameworks and their intersection with quality and operational risk.
• Experience supporting institutional investor due diligence, joint ventures, or licensing transactions is a plus.
• Strong familiarity with SFDA regulatory requirements, CMA Corporate Governance Regulations, and the broader Saudi/GCC regulatory environment.
Skills & Competencies
• Strong analytical and risk-assessment capabilities; ability to translate findings into practical, business-relevant recommendations.
• High personal integrity, independence, and sound professional judgment.
• Excellent written and verbal communication skills in Arabic and English, including Board- and Committee-level reporting.
• Proficiency with ERP systems, audit management software, and data analytics tools (e.g., Excel, Power BI, ACL/IDEA).
• Ability to operate autonomously in a fast-paced, resource-constrained startup environment while maintaining rigorous audit standards.
Location & Employment type
• Location: Jeddah, Kingdom of Saudi Arabia (on-site/hybrid per company policy)
• Employment Type: Full-time
• Travel: Occasional travel to manufacturing/clinical sites and partner locations as required
