Regina Gagan

About Regina Gagan

Quality-focused and visionary leader with 30+ years of experience in creating/implementing GMP-compliant training infrastructures, strengthening quality systems, elevating inspection readiness, and leading high-performing teams across clinical and commercial cGMP environments. History of developing successful quality assurance and training strategy across small-molecule, solid oral dosage, and oligonucleotide manufacturing, integrating regulatory compliance, operational execution, and people leadership to sustain inspection-ready organizations. Repeated success in designing role-based GMP training programs, standardizing curricula and qualification frameworks, improving training completion KPIs, and translating complex regulations into job-relevant, workforce-ready learning. Expertise in FDA cGMP, global regulatory audits, and quality systems governance, recognized for collaborative leadership style, cross-functional influence, and ability to balance hands-on execution with quality and training management.

Experience

1. Qa Manager, Compliance Training Support

   Nitto Avecia

   Dec 2024 — Present

   Manage GMP training governance across the API manufacturing site by coordinating role-based curricula, qualification frameworks, and compliance expectations to maintain inspection-ready operations teams. Lead execution of sitewide GMP onboarding and compliance training while aligning regulatory requirements with job-specific applications across manufacturing, laboratory, and technical functions. Oversee training documentation lifecycle within LMS and quality systems to maintain accuracy, traceability, and audit readiness across training records and curricula. Supervise and influence training resources through direct and matrix leadership and collaborate with department SMEs to align training delivery with operational risk and regulatory priorities.• Achieved 90%+ training completion performance by replacing legacy form-based training with structured, role-driven GMP electronic curricula. This was an improvement from approximately 50% training completion. • Modernized training infrastructure by developing new procedures, documentation workflows, and qualification requirements.• Delivered site-wide training for 200 employees through the development and execution of standardized compliance programs.• Earned strong customer feedback ahead of PAI inspections by elevating SME preparedness through targeted coaching.• Led successful PMDA onsite inspection by coordinating training evidence, SME readiness, and compliance documentation.