Sneha Vyas

About Sneha Vyas

Results-driven with extensive experience in software compliance, digital transformation, and quality systems leadership within regulated environments. Proven ability to align site and quality objectives with corporate strategic priorities to drive operational excellence and business growth. Spearheaded SDLC digitization initiatives to modernize workflows, automate documentation, and achieve FDA 21 CFR Part 11 compliance.Expert in developing and deploying procedures, validation strategies, and QMS integrations for automation and software systems, delivering measurable improvements in Core Value Drivers and KPIs. Adept at leading cross-functional teams, managing complex validation programs, and mentoring technical leaders to ensure compliance with GxP, Annex 11, and global regulatory standards. Recognized as a trusted Subject Matter Expert for Validation readiness as well as audits and regulatory inspections, driving continuous improvement and fostering a culture of quality and innovation.Experienced across manufacturing, pharma, and biotech industries, with strong skills in conducting audits, identifying areas for improvement, and implementing corrective action plans.

Experience

1. Sr Manager, Digital Software Compliance

   Cytiva

   Jul 2024 — Present

   SDLC Digitization Leadership: Initiated and led the transition to a fully digital Software Development Life Cycle using JIRA Discovery, JIRA Cloud, and Confluence. Modernized SDLC by introducing standardized JIRA workflows, custom fields, and automation; implemented compliant approval steps, automated product document creation, and retired legacy eDMS repositories.• Designed and executed a structured, two-phase SDLC rollout plan with clear deliverables, controls, and change-management strategies to support FDA 21 CFR Part 11 readiness.• Accountable for team performance; identified process improvement opportunities and mentored team leads, providing technical expertise and guidance on GxP, 21 CFR Part 11, and Annex 11 compliance.• Provided leadership and oversight to validation teams, ensuring timely and cost-effective delivery of computer system validation activities for regular releases, patches, and hotfixes.

Education

• ICFAI University

  Post Graduate Diploma in Business Management

• ICFAI University

  PostGraduate in Business Administration

• Dharmsinh Desai University

  Bachelor of Engineering - BE, Instrumentation and Controls