Brooke Nelson
About Brooke Nelson
Brooke Nelson serves as the Associate Director of Computer System Validation at Asklepios BioPharmaceutical, Inc., bringing extensive experience in medical regulatory practices across various industries. With a background in managing cross-functional project teams and a solid educational foundation in Biomedical Science and Health Services Administration, Nelson has held key roles in organizations such as KBI Biopharma and Barry-Wehmiller Design Group.
Current Role at Asklepios BioPharmaceutical
Brooke Nelson serves as the Associate Director of Computer System Validation at Asklepios BioPharmaceutical, Inc. (AskBio) since 2021. In this role, she focuses on ensuring compliance and validation of computer systems within the organization. Her responsibilities include overseeing validation processes and ensuring that systems meet regulatory requirements. This position allows her to leverage her extensive experience in the pharmaceutical industry.
Previous Experience at KBI Biopharma
Before joining Asklepios BioPharmaceutical, Brooke Nelson worked at KBI Biopharma as Senior Manager of Computer System Validation and IT from 2018 to 2021. During her three years in this role, she managed validation processes and contributed to IT compliance initiatives. Her work involved leading cross-functional teams to ensure that systems adhered to industry standards and regulations.
Background in Validation and Engineering
Brooke Nelson has a solid background in validation and engineering, having worked at Barry-Wehmiller Design Group as a Validation Specialist/Engineer from 2012 to 2018. In this six-year tenure, she gained experience in various aspects of validation processes and contributed to projects in the Greater Denver Area. Her early career also included a role at Science Care as a Medical Event Steward.
Education and Academic Qualifications
Brooke Nelson holds a Bachelor's degree in Biomedical Science from Colorado State University, where she studied from 2007 to 2011. Additionally, she earned a Master's degree in Health Services Administration from Regis University in 2018. Her educational background supports her expertise in medical regulatory compliance across various industries.
Expertise in Regulatory Compliance and Project Management
Brooke Nelson possesses diverse experience in medical regulatory compliance across the pharmaceutical, tissue, cosmetics, and food industries. She has demonstrated expertise in auditing, nonconformance resolution, and the implementation of corrective and preventive actions. Her skills include managing large cross-functional project teams, conducting gap assessments, and performing program audits to support plant-wide remediation projects.