Janie Miller

As a Director of Global Quality Strategy and Business Operations for Baxter Janie supports strategic direction for external affairs. She comes to Baxter with extensive experience from Amgen GQC (Global Quality Compliance) where she managed activities within the Americas (North, Central & South), in addition to Canada, China, and Singapore. She was a conjugate in developing and shaping global policy/regulations which are consistent with industry best practices. Janie was also the internal lead on competitive intelligence reporting into corporate leadership teams. As the lead for Amgen’s annual GMP training she ensured that staff globally was enabled with the right knowledge and tools to produce high quality medicines. Many of her activities also supported inspection and audit readiness. She also engages with internal and external stakeholders to meet and implement global regulatory expectations throughout the product-life cycle (incl. early-warning signals for compliant quality systems). • ISPE Co-Chair of Regulatory and Quality Biotech CoP • ISPE Women In Pharma Committee member • ISPE Chapter Chair Good Practice Guide Quality 4.0 • ISPE Chapter Chair Continuous Manufacture of Biotech Good Practice Guide