Adrienne Schroll, MSc
Quality and Regulatory Expert
Senior Consultant Medical Devices
Adrienne Schroll has joined the Qserve Group within the medical devices team as a Quality and Regulatory Expert and is based in the US.
Adrienne has an MSc in Regulatory Affairs and Quality Assurance and a Drug Development Certificate, both from Temple University School of Pharmacy in Philadelphia, Pennsylvania (US), and a BS in Microbiology from the University of Minnesota, Minneapolis (US). Adrienne is a versatile Quality leader with over fifteen years of experience within the pharma and medical device (MD) industries. She is a proven problem-solver, resolving issues using investigational tools and the application of knowledge to effectively communicate a solution.
Adrienne about working at Qserve
“I’m excited to be able to utilize the skills I’ve built over the past 15 years and help others understand, implement and improve their quality management systems.”
Adrienne has experience in the design and development of active implantable devices, contract manufacturing including management of sterilization (EtO and gamma radiated product) and test laboratories as high-risk suppliers for medical devices and combination products (including management of sterilization validations). She also has experience manufacturing active pharmaceutical ingredients (API) for biologics, in-vitro diagnostic (IVD) reagent manufacturing, manufacturing, and post-market activities for high and low-risk medical devices, including active implantable devices, single-use medical device reprocessing and food microbiology.
Adrienne is skilled in the development and implementation of quality management systems, establishing and driving site-wide quality objectives, and providing leadership necessary improvement to quality system procedures. She identifies areas of risk to compliance via proactive monitoring, development, and management of processes related to quality systems.
The key expertise areas of Adrienne:
- Experience in highly visible quality leadership roles in MD ensuring quality performance and delivery of the company outputs and deliverables meeting expectations of clients while adhering to internal and external standards and guidelines.
- Successful with ensuring compliance with ISO 13485:2016 and US FDA 21 CFR Part 820 within multiple medical device manufacturing sites.
- Experience assisting clients with MDR readiness through audits, gap assessments, reviewing clinical documents with respect to requirements, including CEP/CER, PMCFP/PMCFR and SSCPs.
- Extensive knowledge of quality management systems including implementation and management of electronic QMS systems for document management, training programs, change control, CAPA, supplier management, nonconforming material reports, and deviations.
- Successfully maintained FDA registration and successfully audits by the US FDA, ANVISA, South Korea MFDS, and Japan.
- ISO 9001:2015 Lead Auditor Certification (Nov 2021) – issued by TUV SUD.
- Extensive experience implementing and managing supplier quality management programs for high-risk medical devices.
- Worked extensively with material change management as it relates to sterilization validation and supplier management.
- Experience writing and executing lab system qualifications including computer system validations in support of GMP operations within a pharmaceutical manufacturing site.
- Advanced understanding and experience developing, implementing, and managing environmental monitoring programs for controlled areas within medical and pharmaceutical manufacturing sites. Extensive experience with data management collected from EM programs as it relates to sterilization validations of medical devices.
- Experience conducting cleaning validations on reprocessed single-use medical devices testing for the presence of residuals through protein, carbohydrate, and total organic carbon (TOC).
- Extensive experience as a QC Microbiologist, leading a team of analysts working with implantable medical devices, IVD reagents, and biologics.