About Us

I am a strategic and results-driven Quality Assurance Leader with 17+ years of biopharmaceutical experience (both commercial and clinical), specializing in GMP Supplier Quality Management (SQM), audits, regulatory compliance, and risk-based quality oversight. My expertise is in developing risk-based programs, conducting domestic and international supplier audits, establishing and negotiating quality technical agreements (QTAs), and fostering cross-functional collaboration to ensure compliance with international regulations/ guidelines. I have a proven track record in designing/developing new processes, improving/streamlining existing processes, leading teams, and delivering measurable improvements in supplier oversight and management.

While SQM and Audits are my areas of expertise, I also have a vast array of experience with developing and enhancing other Quality Management Systems (QMS) elements, including: Document Writing, Training, Deviations & Investigations, Corrective and Preventive Actions (CAPAs), Change Management, Quality Risk Management (QRM) Integration, and more.

If you're in need of any help with your QMS, please use the Contact Form to initiate an inquiry so we can discuss your specific needs, requirements, and challenges.