We’re excited to announce that Shivakumar Swamy has joined PointCross Life Sciences as our Head of Quality & Compliance.
Shivakumar brings over 25 years of experience, including 17+ years in the Life Sciences and Pharmaceutical industries, with deep expertise in:
- IT Quality Management & Regulatory Compliance
- Computer System Validation (CSV)
- GxP / 21 CFR Part 11 Compliance
- Quality Management Systems (QMS) and Audit Readiness
Throughout his career, Shivakumar has held leadership roles at top-tier organizations such as IQVIA, Saama Technologies, Philips, Capgemini, and Accenture, where he spearheaded initiatives in system qualification, validation planning, information security, and training management.
At PointCross, Shivakumar will lead the design, implementation, and oversight of our quality and compliance frameworks, focusing on:
- Software Quality Assurance – Ensuring compliance in product design, development, and release processes
- System Validation – GxP validation, Annex 21 compliance, and automation of evidence generation
- Training & Certification Programs – Enhancing employee training standards and certification tracking
- Regulatory & Audit Readiness – Supporting ISO 9001, ISO 27001, GCP, GDPR, and data privacy compliance
- Business Continuity – Risk identification, mitigation planning, and CAPA implementation
With his hands-on knowledge of tools such as HP ALM, JIRA, and ServiceNow, Shivakumar will play a key role in driving regulatory confidence and operational excellence across our solutions and services.
Shivakumar is based in Bengaluru, India, and can be reached at shivakumar.swamy@pointcross.com.