Michael Ribic Email & Phone Number

Cambridge, Ma

1. Quality Assurance representative on global CMC / Clinical Supply teams in multiple therapeutic areas. My role is to be the single point of contact for QA in support of manufacture and release of API, drug product and packaged clinical supplies as per GMP/Annex 13 and other global regulations, regulatory filings, & clinical protocols. - a. R&D Quality Assurance Team support for FDA Preapproval Inspections and FDA GCP Audits (2014-2016)2. Perform Regulatory release by assuring clinical supplies comply with respective Clinical Trial Applications (US & EX-US).3. GMP QA contact for Recalls and Product Actions4. Perform GMP Due Diligence on companies involved in prospective Abbvie partnerships, licensing, or acquisitionsRetired from AbbVie as of 1 October 2016

•Quality Assurance representative on global CMC / Clinical Supply teams in multiple therapeutic areas. My role is to assure QA supports manufacture and release of API, drug product and packaged clinical supplies as per GMP/Annex 13 and other global regulations, regulatory filings, & clinical protocols to meet project timelines. •Work with Quality Assurance units in Lake County, IL and Ludwigshafen, Germany (GMP and GCP) to assure harmonization and globalization of QA processes. •Perform GMP Due Diligence on companies involved in prospective Abbott partnerships, licensing, or acquisitions.

Project Manager for Abott Clinical Trials assuring GMP Clinical Supplies are provided to perform the trials.

Project Manager for GPRD Quality Assurance providing QA support for all aspects of Abbott Clinical Trials.

Manager of the Quality Assurance GMP Documentation group (supervised staff of three full-time employees) supporting API and Drug Product Quality Organization.

As GLP Compliance Manager, I had two principal functions:1)Managed GLP compliance activities for Regulatory & Discovery Toxicology in Skokie, IL & St. Louis, MO. This function included integrating site procedures, training, process improvement, departmental SOPs, and GLP audits of internal and external contract facilities. 2)Departmental representative for FDA GLP inspections in Skokie, IL & St. Louis, MO (1998 and 1999) & all corporate audits.

Executive Certificate In Transformational Nonprofit Leadership

Certificate In Nonprofit Management

Zoology