William O'Connell
Seattle, WA | (206) 551-5524 | WilliamOConnellPMP@gmail.com | LinkedIn | Resume

Senior TPM · GxP BA · Founder, Untangle2Grow.comGxP / Life Sciences · Cloud · Regulated AI

Available: 3–6 month contracts · GxP / 21 CFR Part 11 · Cloud Migrations · AWS SA · PMP · Fast ramp-up

With over 20 years in IT delivery and cloud transformation — including migrations to 100K+ users and directing $100M+ programs — I know how to deliver at scale. Much of my 14 years at Genentech and Roche included leading BA and TPM work on GxP systems for manufacturing and quality: TrackWise QMS, CAPA, and Change Control — the exact systems Life Sciences companies are now migrating to the cloud.

In 2025 I built a production AWS serverless GxP-aligned document control platform using the same audit architecture as Veeva Vault — and a separate AI safety wrapper on Amazon Bedrock showing how regulated companies can leverage AI to improve productivity without compromising compliance. As Life Sciences companies migrate from TrackWise to Veeva, my institutional knowledge of GxP compliance architecture, validated system delivery, and large-scale cloud migrations makes me effective on both sides of that migration.

My focus: Helping companies of all sizes do it right the first time. Clear ownership, explicit controls, and evidence you can defend under audit.

Roche / Genentech Delivery Track Record:$100M+ delivery100K+ users migrated$20M+ cloud savings100+ resources led

Recently launched Untangle2Grow.com — a fractional TPM advisory service for smaller Life Sciences companies to help them build accountable governance, scalable processes, and clear handoff discipline at a fraction of the cost of a full-time hire.