Develop a flexible, risk-based annual audit plan using appropriate methodology, in consultation with senior management and the Audit Committee.
- Lead the planning, scoping, and execution of financial, operational, and compliance audits across all functional areas.
- Conduct audits of critical processes including, but not limited to:
o Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) compliance.
o Procurement and supply chain logistics (controlled substances, cold chain).
o Research & Development (R&D) project accounting and controls.
o Sales and marketing practices (including compliance with anti-bribery and ethical promotion codes).
o IT systems (including data integrity for laboratory and manufacturing systems - 21 CFR Part 11, Annex 11).
o financial reporting and entity-level controls.
Risk Management & Compliance:
- Evaluate the effectiveness of the company's risk management framework and contribute to its improvement.
- Assess the adequacy and effectiveness of internal controls in mitigating key business risks.
- Ensure audits verify compliance with Egyptian Drug Authority (EDA) regulations, Financial Regulatory Authority (FRA) standards, tax laws, and international standards like ISO and ICH guidelines.
Reporting & Communication:
- Prepare clear, concise, and impactful audit reports for senior management and the Audit Committee, detailing findings, risks, and practical recommendations.
- Discuss audit results and recommendations with process owners to develop agreed-upon action plans.
- Track and validate the implementation of management's corrective actions to closure.
Investigation & Advisory:
- Lead or assist in investigations into suspected fraudulent activities, breaches of code of conduct, or regulatory non-compliance as required.
- Provide advisory services on new systems, processes, and changes in regulations to help management embed controls from the outset.
Department Leadership:
- Manage, mentor, and develop the internal audit team, fostering a culture of continuous learning and professional excellence.
- Manage the department's budget and resources efficiently.
- Stay abreast of emerging trends, best practices, and changes in regulations affecting the pharmaceutical industry and the audit profession.
Job Type: Full-time