At Amgen, I lead Global Distribution Quality and Global Supply Quality across 84 countries with a team of 24 associates. I drive continuous improvement that reduced oversight visits to downstream distributors in India and China, saving approximately 3 FTE.
I oversee supplier supply-security and GMP audits in the JAPAC region, along with cold-chain distribution quality. I also work with Safety, Regulatory Affairs, and Supply Chain teams on the affiliate distribution model.
At Novartis India Pvt. Ltd. (Sandoz Division), I led work across IPQA, batch release, customer complaints, CAPA, and quality risk assessment. I investigated and closed more than 1,000 complaints, including approximately 50 critical complaints, with no product recalls, and supported FDA 483, Warning Letter, and RAI responses.
I bring experience across manufacturing and distribution quality, including data integrity, remediation, and regulatory response. At Amgen, I use Power BI, Smartsheet, and generative AI tools to support quality and compliance workflows.
