I have over 10 years of experience in managing quality and regulatory compliance in the pharmaceutical industry. I have successfully implemented quality management systems that meet FDA and ISO standards, ensuring compliance withcGMP regulations. My experience includes leading audits, managing CAPA systems, and driving continuous improvement initiatives to enhance product quality and regulatory readiness.

I regularly attend industry conferences, participate in professional associations, and subscribe to regulatory updates and newsletters. I also conduct regular training sessions for my team to ensure they are aware of the latest changes. This proactive approach helps us stay ahead of regulatory changes and maintain compliance.

One challenging issue was a major non-compliance during an FDA audit. I led a cross-functional team to investigate the root cause, implement corrective actions, and prevent recurrence. We developed a comprehensive CAPA plan, which included process improvements and employee training. The issue was resolved within the specified timeline, and we successfully passed a follow-up audit.

I foster open communication by holding regular meetings with department heads to discuss compliance issues and updates. I also create cross-functional teams to address specific compliance challenges. By promoting a culture of transparency and collaboration, we ensure that all departments are aligned and working towards the same compliance goals.

I implement a robust quality management system that includes regular internal audits, performance metrics, and feedback loops. I encourage a culture of continuous improvement by rewarding innovative ideas and best practices. Additionally, I leverage data analytics to identify trends and areas for improvement, ensuring that our processes are always optimized for quality and compliance.