Tell us about a time when you had to make a difficult decision regarding non-compliance.

In my previous role as a Regulatory Auditor for a pharmaceutical company, I encountered a difficult decision regarding non-compliance with FDA regulations. During an audit, I discovered that the company was not properly documenting the temperature controls for a specific storage area, which could potentially compromise the integrity of the products. I immediately reported the issue to the senior management and recommended implementing a more robust tracking system to ensure accurate temperature monitoring. After consulting with the quality control team and conducting a risk assessment, we decided to temporarily halt production in that area until the necessary changes were made. This decision was difficult because it meant delaying production and potentially impacting revenue. However, I prioritized the safety and compliance of the products over short-term financial goals. The implementation of the new tracking system not only improved compliance but also increased the efficiency of temperature monitoring, resulting in enhanced product quality and customer satisfaction.

During my time as a Regulatory Auditor at a medical device company, I faced a challenging situation involving non-compliance with ISO 13485, an industry regulation for quality management systems. While conducting an audit, I discovered that the company had not implemented a corrective action plan for a recurring non-conformity, which could potentially jeopardize product safety. Recognizing the importance of addressing this issue promptly, I organized a meeting with the quality team to discuss the root causes of the non-conformity and develop an action plan. As the team leader, I delegated tasks, set deadlines, and ensured open communication among all stakeholders. We conducted a thorough investigation, identified the gaps in the existing processes, and implemented appropriate corrective actions. I regularly updated the senior management on the progress and provided recommendations for process improvements to prevent future non-compliance incidents. This decision was difficult as it required balancing the need for immediate action with the need for a sustainable solution. In the end, our efforts not only resolved the non-conformity but also improved overall quality and compliance within the organization.

While working as a Senior Regulatory Auditor at a financial institution, I encountered a complex decision regarding non-compliance with anti-money laundering (AML) regulations. During an audit, I discovered significant deficiencies in the institution's customer due diligence process, which posed a high risk of potential money laundering activities. These findings were particularly concerning given the institution's international operations and exposure to global financial risks. To address this issue, I immediately initiated a cross-functional task force, consisting of representatives from compliance, legal, and operations departments, to conduct a comprehensive review of the existing AML policies and procedures. We collaborated with external experts to gain insights into best practices and regulatory expectations. Based on our findings, I developed a detailed action plan that involved updating the institution's customer risk assessment model, enhancing transaction monitoring systems, and providing extensive staff training. Recognizing the urgency of the situation, I effectively managed multiple projects and priorities by establishing clear timelines, allocating resources, and ensuring regular communication among team members. I also presented the findings and recommendations to the senior management and the board of directors, emphasizing the importance of immediate action. As a result of our efforts, the institution successfully implemented the recommended changes, significantly reducing the risk of non-compliance and strengthening its AML framework.