Walter Chappas

Background

About Walter Chappas

Quality & Supplier Governance leader in pharma/biotech with 10+ years of experience. When supplier-quality resources were reduced, I assumed global ownership of supplier complaints (SCARs) across five internal sites and multiple CMOs. To sustain compliance and throughput, I built AI-assisted (ChatGPT) tools outside Veeva—with human-in-the-loop review and final entry into Veeva EQMS—covering reporter intake, SCAR drafting, communication review, investigation-report feedback, and QAA review/drafting. Using decision-tree logic and templates I developed, the approach cut manual workload ≈ 80 % while improving consistency and maintaining GMP / Annex 11 / 21 CFR Part 11 expectations. Earlier, I led a team of five managing all ex-US SCARs (raw materials & 3PL) plus supplier qualifications and quality agreements, aligning processes across regions. At Biogen, I optimized complaint workflows and analytics (TrackWise, Tableau, Oracle R12) to support inspection readiness. I focus on making quality systems smarter, simpler, and compliant by design—bridging QA, operations, suppliers, and IT.