Baxter
Head of Global Quality External Affairs, Strategy and Business Operations
As the Head of Global Quality External Affairs within Strategy and Business Operations for Baxter, Janie drives best practice development and implementation within the organization in addition to leading multiple industry efforts. 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 were 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 CBA Advisory Council
• ISPE Chair of Regulatory and Quality Committee- Biotech CoP
• ISPE Women In Pharma Steering Committee
• ISPE Chapter Chair Good Practice Guide Quality 4.0
• ISPE Chapter Chair Continuous Manufacture of Biotech Good Practice Guide