Risk and Audit Governance Specialist
A highly exciting software company who have recently entered the Dublin market are seeking a Risk and Audit Governance Specialist to join their Dublin city centre business.
Key Accountabilities of the Risk and Audit Governance Specialist:
- Perform risk investigations of risks identified from the ERM program
- Assists with defining and improving all related processes within the remit of the role
- Host client audits, from start to finish which would include all pre-audit work and post-audit responsibilities
- Prepare fully for upcoming audits and investigations to ensure all possible documentation, subject matter expertise, systems and other forms of evidence are fully available and in best order
- Conduct and host audits and investigations professionally and courteously and ensure best current practices are employed
- Ensure valid findings from the audit/inspection report are managed effectively by the organization, and in accordance with our procedures
- Collaborate with management to review and potentially correct issues and findings
- Assist management with enforcing and improving the ERM program
Key Skills & Attributes of the Risk and Audit Governance Specialist:
- Previous knowledge and experience in audit and inspection management, and management of audit programs
- Real-world auditing experience having worked as an auditor in a major consulting/accountancy/auditing firm
- ERM compliance/development experience
- Risk management and mitigation
- Comprehensive knowledge of the clinical trials process, relevant regulations (e.g., FDA, MHRA, EMA), ICH Guidelines
- Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions
- Strong understanding of software development and healthcare technology systems
- Solid computer literacy and able to function independently within an environment that relies on technology for information and communication
- Knowledge of governmental regulations impacting clinical research and drug development
- Flexibility, open-mindedness and adaptability to a rapidly changing environment; able to develop strong working relationships with key stakeholders; able to manage competing priorities.
For a confidential conversation regarding this position please apply or reach out to James Brown at 085 871 9083 or firstname.lastname@example.org.
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