SREEJITH “SREE” KANHIRANGADAN

Technology Quality · CSV/CSA · Data Integrity · AI-Enabled Validation & Governance

Sree Kanhirangadan is a technology quality and validation leader with 20+ years across the full spectrum of life sciences — big pharma and biotech (Amgen), mid-size clinical-stage companies (Sarepta Therapeutics), and startups — spanning the US, Germany, and India. He has led enterprise digital-quality transformations at scale: a 40,000-user, 1M+ document migration to Veeva Quality Vault, a validation and testing practice he grew to  $7M with a team of 100+, and risk-based CSA adoption that delivered 4x savings in time and cost. He is the founder of EvoLV, an AI-native validation platform whose independent-verifier architecture and hash-chained audit evidence define what AI/ML-enabled validation and AI governance look like in a GxP world. A sought-after voice in the industry — educator to 10,000+ professionals, podcast guest, published author, and trusted counterpart to C-level leaders across sponsors and service providers — Sree brings clients not just compliant systems, but confident programs.

EXPERTISE PILLARS

Technology Quality & Compliance

GxP quality across the system lifecycle — 21 CFR Part 11, EU Annex 11, GAMP 5, SOX, GDPR; audit readiness, deviations/CAPA, change control, FDA audit prep support.

CSV / CSA Transformation

Early advocate and practitioner of FDA’s risk-based CSA; converted enterprise validation programs to critical-thinking, risk-based models with 25–30% effort reduction and 4x cost/time benefit.

Data Integrity & Data Governance

Enterprise document and data governance ownership; 165k-document migration oversight; data integrity and impact assessments; ALCOA+ aligned migration and sampling strategies (ANSI).

AI/ML-Enabled Validation & AI Governance

Founder of EvoLV: two-agent AI validation (drafting + independent verifier), hash-chained audit evidence, real-time traceability — plus enterprise GPT deployment and AI adoption governance for regulated teams.

Enterprise Platforms

Veeva Quality Suite (QualityDocs 8 yrs, QMS 7 yrs; RIM, eTMF, CTMS domain), Salesforce, cloud GxP (AWS/SaaS), Agile/DevOps, automation, Tableau/JIRA.

Program & Practice Leadership

Led 100+ member delivery organizations across 25+ programs; owned budgeting, contracts, risk; built a Testing Center of Excellence from 2 to 80 members over 10 years.

 

SELECTED RESULTS

 

  • Enterprise transformation: led business-side transition of a 40,000-user, 1M+ document platform from Documentum to Veeva Quality Vault; town halls to 500+ global staff; featured in enterprise launch video alongside SVP leadership.
  • Speed with compliance: delivered Veeva QualityDocs, Training, and QMS in 6 months with 25% effort reduction; ANSI sampling-based migration testing saved a further 30%.
  • Practice growth: grew validation/testing portfolio  to $7M; led $10M life-sciences digital-transformation accounts across Veeva, Salesforce, AWS.
  • Recognized: twice awarded by Amgen’s CISO (2018, 2019) for strategic information-systems initiatives; “the glue between Veeva and customer” — client feedback.

 

CAREER SNAPSHOT

 

  • Founder & CEO, EvoLV — AI-native CSV platform (2023–present)   IT QMS Validation Consultant, Sarepta Therapeutics (2021–present)  ·  Consulting Leader serving Amgen — 4 leadership roles incl. GFA Business Lead, DMS Lead, ISRA, 100+ member Validation/Testing Lead (2007–2021)  ·  System Testing Lead, Tecan Europe — Frankfurt (2004–2007)

 

THOUGHT LEADERSHIP & CREDENTIALS

 

  • Educator to 10,000+ life-sciences professionals across 11 courses   Podcast guest and industry speaker  ·  Author, “Busy Life Easy Life”  ·  Two weekly industry newsletters on validation and AI adoption  ·  B.Tech, Computer Science (Mahatma Gandhi University)  ·  PMP  ·  Executive MBA selectee, Pepperdine Graziadio  ·  Stanford (Creativity)  ·  AWS Solutions Architect coursework