About Us

✦ Vendor / Supplier Quality Management (SQM) Professional & GMP Compliance Expert ✦

With over 17 years of experience in the biopharmaceutical industry (10+ years in QA), I am a Strategic Quality Assurance Leader specializing in GMP Supplier Quality Management (SQM), risk-based oversight, and data-driven compliance solutions tailored to meet the unique needs of each organization. I have a proven ability to develop and refine vendor lifecycle approaches that align with global regulatory requirements/guidelines (FDA, EMA, ICH) while implementing right-sized audit, monitoring, and risk mitigation measures. I am an expert in leveraging risk-based principles to proactively assess and mitigate risks, foster cross-functional collaboration, and enhance supply chain integrity—ultimately safeguarding patient safety and product quality. I am adept at building sustainable frameworks, cultivating strong supplier partnerships, and driving continuous improvement. I am skilled at translating complex regulatory requirements into practical, scalable oversight strategies that align with business goals, industry best practices, and evolving compliance expectations. I am passionate about training and mentorship, having crafted programs that enhance operational awareness and drive excellence across organizations.

While SQM and Supplier 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 Development & Delivery, Quality Risk Management (QRM) Integration, Deviations & Investigations, Corrective and Preventive Actions (CAPAs), Change Management, and more. 

Please take a look at my Service Offerings page for a full list of services. 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.