Gregory Colacino

Accomplished quality professional with extensive experience supporting and influencing multinational organizations to maintain agility, efficiency, and effectiveness. Adept at partnering with key stakeholders to implement Data Integrity strategies, raise awareness and achieve sustainable results. In-depth experience supporting Manufacturing, Quality Control, and Quality Assurance within the Pharmaceutical Industry, growing to Global Quality.

Proven success in improving Data Integrity (DI) at manufacturing sites by developing a bottom-up Global DI strategy focused on a proactive back-to-basics approach. Global business experience in Switzerland, Italy, France, Spain, United States, Netherlands, Brazil, Germany, Mexico, Canada, Puerto Rico, and Ireland.

Bristol Myers Squibb, Bothell,Washington October 2024 – Current

Senior Manager, QA Data Integrity 

Develop and monitor progress against the site Data Integrity Master Plan. Oversee implementation of corrective and preventive measures (CAPAs) related to DI, and drive escalation and investigation process for DI issues while coaching and training associates to achieve a consistent and compliant state of DI control. Monitor DI issues and escalations, capturing trends to identify proactive Initiatives and opportunities for improvement business process at the site.

• Developed a site Data Integrity Master Plan.
• Rolled out the Data Integrity Champions network to raise awareness of DI events and to promote the importance of DI with the functional area.
• Collaborating with DI Champions to identify challenges in the respective areas to ensure associates apply the DI principles to their daily work.
• Developing a DI decision tree to help triage teams and lead investigators determine if the event is DI related or not and standardized on an escalation path to notify department heads and Quality Assurance.
• Promoting communication through regular discussions, DI News on TV monitors, DI moments, and engagement exercises at site to focus on factors impacting the decision-making process and assess challenges which impede good DI compliance.
• Conducting DI walkthroughs based on deviation trends.
• Supported audit and inspections of key DI related topics for both internal organizations and external parties at the site.

Associate Degree - Computer Information Systems - Union College, New Jersey

Certificate - Computer Repairs and Robotics - Cittone Institute, New Jersey