Chris Mondello

Sr. Compliance Consultant

Chris Mondello joined the QACV Consulting team in March 2020. Prior to QACV, Chris’ experience in the pharmaceutical and biotech industries spans several decades. That experience includes:

• working on and leading a pharmaceutical R&D software development organization that focused on building real-time laboratory automation applications,
• managing a wide variety of electronic system validation projects,
• conducting many workshops on computer system validation and FDA’s 21 CFR Part 11 regulation, and
• leading an electronic system compliance group that was responsible for providing oversight and guidance on all systems used in a variety of pharmaceutical / biotechnology R&D areas, and other functional areas, including pharmacovigilance, clinical operations, regulatory operations, medical affairs, biostatistics, data management, non-clinical laboratories, and legal records systems.

Since joining QACV he has conducted upwards of 100 third-party and internal audits for our clients. Chris holds these certifications from the American Society for Quality:

• CQA – Certified Quality Auditor (certification #42361) since 04-Jun-2011
• CSQE – Certified Software Quality Engineer (certification #5206) since 02-Jun-2012

He also has an ITIL Foundation Certificate in IT Service Management from the PEOPLECERT Group (certification #GR750047997CM) dated 21-Feb-2013.

Chris earned an M.S. in organic chemistry from Northeastern University (Boston), and a B.S. in chemistry from Houghton College (now Houghton University, Houghton, NY).

Chris is a member of the board of directors for Project Response (Brevard County, Florida), a non-profit organization that has provided a safe space for HIV/AIDS services for over 30 years.