Janie Miller
Amgen Inc
As a Director of Global Quality Strategy & Business Operations
External Affairs
for Baxter, Janie facilitates shaping global policy/regulations which are consistent with Baxter's mission and vision of saving and sustaining lives. Through gathering and sharing GxP intelligence throughout the organization, Janie supports the development of many innovative strategies. She also engages with internal stakeholders to meet and implement global regulatory expectations throughout the product-life cycle (incl. early-warning signals).
She is the current chair of the PhRMA Quality GQM workstream and supports other QMM industry efforts, and is the co-chair of the ISPE Quality and Regulatory Advisory Board.
Janie comes to Global Quality Strategy & Business Operations with over 20 years of industry experience from Amgen where she was had oversight of the engagement strategies for the Americas, Canada and China. PDA (Parenteral Drug Association) where she was responsible for all regulatory activities and initiatives globally of the Science Advisory Board. She worked collaboratively with PDA members and governing bodies to facilitate the production of PDA Responses to Draft Regulatory Guidance Documents, Technical Reports, Points to Consider Guidance’s, Training Courses and Strategic Plans. Prior to joining PDA in 2012, Janie worked as a clinical manager for Otsuka, an account director at OneWorld, and a research scientist at Johnson & Johnson. Janie holds a Bachelor of Science Degree in Biomedical Sciences and a Master’s Degree in Business Management.
External Affairs
for Baxter, Janie facilitates shaping global policy/regulations which are consistent with Baxter's mission and vision of saving and sustaining lives. Through gathering and sharing GxP intelligence throughout the organization, Janie supports the development of many innovative strategies. She also engages with internal stakeholders to meet and implement global regulatory expectations throughout the product-life cycle (incl. early-warning signals).
She is the current chair of the PhRMA Quality GQM workstream and supports other QMM industry efforts, and is the co-chair of the ISPE Quality and Regulatory Advisory Board.
Janie comes to Global Quality Strategy & Business Operations with over 20 years of industry experience from Amgen where she was had oversight of the engagement strategies for the Americas, Canada and China. PDA (Parenteral Drug Association) where she was responsible for all regulatory activities and initiatives globally of the Science Advisory Board. She worked collaboratively with PDA members and governing bodies to facilitate the production of PDA Responses to Draft Regulatory Guidance Documents, Technical Reports, Points to Consider Guidance’s, Training Courses and Strategic Plans. Prior to joining PDA in 2012, Janie worked as a clinical manager for Otsuka, an account director at OneWorld, and a research scientist at Johnson & Johnson. Janie holds a Bachelor of Science Degree in Biomedical Sciences and a Master’s Degree in Business Management.