Sue Soderholm
Managing Consultant
Sue graduated from Carroll University with a Biology Degree and completed her Nuclear Medicine training in Milwaukee, WI.
Her career started in Pharma and Med Devices at Abbott Laboratories prior to the split off of Hospira and AbbVie. She worked in the Diagnostics Division and the Pharmaceutical products division where she gained lab and product launch experience, FDA remediation experience, automated software introduction for electronic batch records (EBR) and ran the clinical pilot plant while there. She trained in excess of 1,000 employees on various critical FDA required remediations activities.
Sue also has extensive experience with injection blow molding and flexible packaging working as well as Cold chain experience.
Sue obtained her Master Six Sigma Black Belt through Villanova University and employs the lean and continuous improvement methodologies in her approach to compliance issues. Her tenure at Hospira/Pfizer combined best practice activity on a global basis to ensure consistency across the company and all sites.
Sue has presented at conferences to address current needs and deficiencies seen through the eyes of the regulatory bodies in the life-sciences industry. She brings over 30 years of both Medical Device, Pharmaceutical manufacturing of solid oral dose and sterile injectables, Cold Chain technology and packaging experience to Compliance Architects®.
Sue enjoys outdoor sports, cooking, wine tasting, the Chicago Cubs and Green Bay Packers, and spending time with her family.
