Experienced Senior pharmaceutical Quality Assurance Consultant with 20 years of experience managing all aspects of Global Product Complaints. Deep understanding of both regulatory and internal expectations to drive a compliance mindset across the organization.
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Led Global Product Complaint (PC) Management including the following:
I was hired at Lilly as a Consumer Technical Services representative. The role was a product complaint coordinator for the US. I was one of two Pharmacists that had responsibility for reviewing product complaints from the US call center, determining the need for return of product, assessing physical aspects of returned product, sending to the manufacturing/packaging site for investigation, and responding to the patient. Responsible for annual controlled substance review of returned product complaint samples. Periodically, I would travel to the US call center to review complaint management process and work with the call center management to improve complaint intake process. I managed our third party manufacturers, reviewed quality agreements and provided complaint data. Early 2002 I was promoted to Global Complaint Consultant (Associate Sr Consultant QA). There was a period of time where I performed the role above and the Global Complaint Consultant role.
Registered Pharmacist 1980 until 1992: I started as an Assistant Manager and gained management experience as I moved and worked at three different stores. In 1985, I was promoted to Store Manager and successfully managed two different stores in the Indianapolis area. Responsibilities included the following:
All store functionality:
From 1992 to 1995, I was the Assistant pharmaceutical buyer. My responsibilities included:
I have been involved with Special Olympics (in Johnson County, Indiana) for the last 15 years. I have been on the county management team for ten years and served as the treasurer overseeing the annual budget. I am currently serving as the County Coordinator with the overall accountability for the program.
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