Gregory Colacino

About Gregory Colacino

As an experienced quality professional, I work to support and influence multinational organizations in their mission to maintain agility, efficiency, and effectiveness while partnering with key stakeholders to rollout Data Integrity strategies to raise awareness, and have sustainable results. Over 30 years of experience supporting Manufacturing, Quality Control, and Quality Assurance areas within the Pharmaceutical Industry with progressive responsibilities within Global Quality. Improving Data Integrity (DI) at the manufacturing sites by developing a bottom-up Global DI Strategy, with focus on a proactive back-to-basics approach regarding DI. Global business experience working in Switzerland, Italy, France, Spain, United States, Netherlands, Brazil, Germany, Mexico, Canada, Puerto Rico, and Ireland.

Experience

1. Global Data Integrity Officer

   Advanced Accelerator Applications

   Dec 2019 — Present

   Drive and support site level implementation of behavioral culture change and business process improvements to enhance Data Integrity (DI) controls within Advanced Accelerator Applications sites worldwide. Monitor progress against the DI Plans at the site level, oversee implementation of corrective and preventive measures (CAPAs), and drive the escalation and investigation process for DI issues at the sites while coaching and training sites to achieve a consistent and compliant state of DI control. • Lead the drive to change human behaviors and culture relevant to ensuring DI across sites, including functional management of DI Leads and other DI and e-Compliance SMEs • Promote communication through regular discussions, awareness, and engagement exercises at site level to focus on factors impacting the decision-making process and assess challenges which impede good DI compliance • Support audit and inspections of key DI/e-Compliance related topics for both internal organizations and external parties at the global and site level • Conduct Data Integrity Site visits • Participate in site Data Integrity walkthroughs and track corrective actions • Educate and coach the site DI lead, DI area Champions, and site Quality to move from “Awareness” to “Understanding” and establish Quality culture in place with a strong detection process • Collaborate with DI Champions initiatives in leading the implementation of the DI Plan • Discuss Data Integrity issues with sites and brainstorm solutions for systematic challenges with Data Integrity observations • Trend Data Integrity events to help sites identify opportunity areas for improvement and prevent Data Integrity issues from reoccurring • Develop best practice guides for the sites to identify challenges and ensure that associates apply the DI principles to their daily work • Engage in inspection readiness related to DI at the site level to ensure preparedness for regulatory inspections