Gina Digioia

About Gina Digioia

With extensive experience in Quality Assurance and Operations, I am currently serving as the Director of Quality Assurance at AbbVie. I am committed to ensuring robust quality standards while driving operational excellence in line with the company\'s mission of delivering innovative healthcare solutions. My expertise in PCR, microbiology, and molecular genetics enables me to bring a scientific and meticulous approach to quality oversight while fostering collaboration across teams to ensure the highest product standards.

Experience

1. Director of Quality Assurance

   AbbVie

   Jan 2026 — Present · Branchburg, NJ, US

   Lead, develop, and direct a high-performing, multi-disciplinary Quality organization, including overseeing the recruitment, succession planning, talent development, and performance management of Quality managers, engineers, and analysts across multiple departments.• Serve as the primary Quality interface with senior Operations, Quality Control, Supplier Quality, Process Engineering, and Validation leadership on site related project activities.• Establish and enforce accountability frameworks for quality and process excellence across the organization.• Oversee the governance of Nonconformance (NCR) and Corrective and Preventive Action (CAPA) programs, ensuring effective investigation, timely closure, and sustainable effectiveness. • Serve as SME for site and cross-site risk management activities, including comprehensive risk identification, mitigation, and communication for all critical processes, equipment, systems, and change controls. • Collaborate as a senior partner with cross-functional Quality, Operations, Regulatory, and Business leadership to resolve critical and escalated quality issues. • Provide strategic leadership and representation in enterprise-level cross-functional projects and external collaborations. Influence project priorities and objectives to ensure alignment with regulatory, compliance, and business strategies.• Provide leadership and oversight over all complex or high-impact investigations (Field Actions, product and material disposition, facility/IT changes), ensuring rigorous, regulatory-compliant processes for timely closure, risk mitigation, and business continuity.• Oversee and drive site regulatory readiness, including proactive engagement with Regulatory Affairs.• Act as a key participant in the development, deployment, and continuous improvement of global and site Quality policies, procedures, and systems, ensuring they are robust, current with industry trends, and harmonized with corporate and regulatory requirements.

Education

• University of Medicine and Dentistry of New Jersey

  PhD, Microbiology and Molecular Genetics

  2001 — 2007

• Drew University

  Bachelor of Arts, Neurobiology

  1997 — 2001