Mariana Nielsen
Quality Assurance and Validation
Mariana has been with Pacific BioDevelopment since 2005 and serves our clients in the areas of Quality Assurance and Validation. She has over 21 years of experience in Quality Assurance at companies such as Genentech, Amgen, and Synergen. Her experience enables her to assess and implement Quality Systems to ensure compliance with rapidly changing FDA guidance. Her many years in various qualification and validation roles have shown her how to write effective protocols and final reports for most types of projects: manufacturing equipment IQ/OQ/PQ, facility validation, cleaning validation, computer validation, and process validation. A consultant for nine years, she knows how to efficiently partner with client teams to ensure critical projects are completed on time.
If you need more assistance in determining which of our experienced consultants might best fit your needs, please contact us.
