Business process owner for quality risk management in R&D(2.6yrs) Risk Management experience(19 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.

After completing a Biomedical Engineering undergraduate degree, I built upon my internship with Abbott (eventually AbbVie) in a 2 year rotational program with different assignments every six months across the business landscape. Since then I've been in the R&D Quality Assurance world, added an MBA and spent the last 6 years helping to build a "Program Management" team in GCP QA. We have aggressively sought opportunities to drive proactive QA in the Development / Clinical landscape via fully embracing the integrated Quality System approach. Our team members support all compounds/assets with a strategic Quality mindset. Critical thinking, Risk and Issue Management have led to successful submissions, inspections and approvals.