Xybion Women in Quality and Compliance: Empowering and Honoring Women for their Contributions

The world celebrates International Women’s Day on March 8, 2023, theme is to embrace equity. We at Xybion are excited to honor our women in Quality and Compliance. Learn more about Xybion Women in Quality and contact us for a consultation on your business needs.

Heidi Krueger – Heidi leads Xybion’s Quality Assurance practice. She has over 25 years’ experience in designing and implementing quality assurance policies. Since joining Xybion (Stelex) in 2000, Heidi has worked with several clients to design quality policies and ensure compliance. She is responsible for hosting Xybion customer audits. Heidi has a BA degree in Biology from King’s College. She lives in Pennsylvania. She has served as the Quality Assurance Manager and/or Director for four companies, including what was then the second largest single site testing lab in the country. She is a member of ISPE and the Society of Quality Assurance (SQA) and 2023 President of the Mid-Atlantic Region Society of Quality Assurance (MARSQA).

Heidi started her career in the life sciences laboratory conducting basic research. As a natural progression she fell into chemical testing, EPA GLP (GOOD LABORATORY PRACTICE), validation, and the quality and compliance realm. She transitioned into the technology side where Xybion provides software as a service that is used by Life Sciences companies to support their processes and regulatory needs. She strongly believes that continuous learning and improvements are the way of life.

Amy Carlson – Amy is a subject matter expert in the Quality and Risk Management domain. She has cross-industrious experience in implementing and launching Quality systems for Life Sciences, Utilities and Public sector verticals. Amy also leads Xybion University and the company’s training initiatives. She has been with the company for over 15 years and worked in compliance for the decade prior to that. With her degrees, her career journey has led her from the Pacific in volcano research to atmospheric forecasting to working in compliance software. She lives with her family near Kansas City, Missouri. Amy ‘s superpower is in driving business analysis and designing solutions to solve complex business problems to improve the quality of people’s lives.

Raji Bijur – Raji leads Xybion’s Validation delivery services globally. She has over 25 years of experience in Quality management in the Life Sciences industry. She has made significant contributions to the Clinical and global data management domains within the industry. She is a resident of Bengaluru in India and holds management degree from Indian Institute of Management in Ahmedabad. Prior to joining Xybion, Raji led Quality and Business Process automation function at IQVIA (a global CRO (Contract Research Organization)). Raji inspires others in the field of Quality. She believes that a healthy work-life balance is the mantra to a Qualitative life and enjoys travelling and learning about diverse cultures. She hikes in the Himalayas as an annual detox with her family and friends.

Anu Ganguly – Anu leads Xybion’s Strategic growth in Quality, Compliance and Risk Management. She has over 20 years of professional services experience with Life Sciences companies and extensive expertise in designing and deploying innovative and transformative solutions with a concentration on clinical trial management, sales, marketing effectiveness, and business intelligence programs. She holds a BS in Computer Science from the University of Maryland College Park and an MBA from Cornell University’s SC Johnson College of Business in Marketing and Strategy. She lives in New Jersey and enjoys the arts, culture, and the outdoors in the tri state area.

Angie Bixler – Angie leads Xybion’s Quality, Compliance and Risk Management product team. She has 20+ years of experience in Quality and Information Technology services in the Life Sciences industry. She is an enthusiastic and committed product manager and IT Quality leader, dedicated to helping partners by designing and leading large, enterprise-level projects and helping them to achieve business transformation. Angie earned her MBA from Indiana Wesleyan University, and she lives in South Bend, Indiana with her family.

Shini Menon – Shini leads Xybion’s Consulting services in Toronto, Canada. She has over 15 years of experience in Risk and Quality management working for large system integrators globally. She has previously worked with Oracle, PwC, KPMG, Deloitte, and Infosys consulting and has led multi-million-dollar deals with all top 10 Pharma. She has co-authored control maturity assessments, implemented transformational internal audit programs utilizing RPA and Machine learning, and has helped set up metrics & measurement frameworks as part of enterprise governance. She holds a master’s in software engineering from Carnegie Mellon University in Pittsburgh, PA. She lives in Toronto, Canada with her family.