Bala Satish Bala Kilaru K.

About Bala Satish Bala Kilaru K.

I am a seasoned Computer System Validation (CSV) and GxP Compliance leader with nearly two decades of experience driving digital transformation for globally emerging life sciences companies. I specialise in delivering audit-ready, risk-based validation strategies across clinical systems, TMF platforms, ERP, SAS analytics, and AI-enabled validation solutions. I hold a Master’s degree in Project Management and bring in-depth experience in GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and global regulatory frameworks. I specialize in scaling offshore delivery centres and driving cross-functional collaboration to achieve operational excellence.I have strong expertise in Computer Systems Validation (CSV), project management, and the Software Development Life Cycle (SDLC) within the life sciences industry. I’ve worked extensively in FDA-regulated environments, ensuring strict compliance with the current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), as well as 21 CFR Part 11 and Annex 11 regulations.I’ve a proven track record of delivering best-practice solutions across all phases of the SDLC process. What excites me the most is the opportunity to integrate AI-driven validation into traditional compliance processes, making them smarter, faster, and more resilient. I am passionate about building high-performing teams and forging partnerships that enable pharmaceutical, biotechnology and medical device companies to grow with confidence and compliance.Let’s connect if you’re looking for a trusted partner to lead validation initiatives, streamline compliance, or future-proof your pharmaceutical systems.Technical Skills: 21 CFR Part 11 (210, 211), EU Annex 11, cGxP (GLP, GMP, GCP), IQs, OQs, UATs.Applications : SAP ERP, RMS, SAS, LIMS, Empower, NuGenesis, Track Wise, QRMS, APPIAN, HP ALM, Service Now, Change Management Database (CMDB), Veeva System, Net suite and BOX Application.

Experience

1. Director Global Csv & Compliance

   Pharmatek Solutions Inc.

   Jun 2023 — Present · San Ramon, CA, US

   Lead global CSV, GxP compliance and clinical, ERP & AI-Driven Validation initiatives for globally emerging pharmaceutical and life sciences organizations. Few clients include Summit Therapeutics, ShockWave Medical, Circle Pharma, Reata Pharmaceuticals, and Validation Cloud. Spearhead validation projects across clinical trial management systems, TMF platforms, SAS analytics, NetSuite ERP, Oracle systems, and AI-enabled validation solutions. Develop risk-based validation strategies aligned with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and global regulatory standards. Strengthened offshore delivery efficiency by 60% through cross-functional team optimization. Partner with IT vendors and quality leaders to scale compliance solutions, system integrations, and digital validation frameworks.Key Achievements: Onboarded and successfully delivered CSV and compliance solutions for key Pharmaceutical and Life Sciences clients. Pioneered AI-driven validation initiatives to automate compliance workflows.

Education

• Tamil Nadu Dr. M.G.R. Medical University , Chennai

  Bachelor of Pharmacy - BPharm, Pharmacy

  2000 — 2004

• Harrisburg University of Science and Technology

  Master's degree, Project Management

  2015 — 2016