Computer Systems Validation Lead
RxCloudSan Francisco, California, United States
Posted December 12, 2025
Full Time
About the Company
RxCloud is a professional services firm dedicated to the pharmaceutical, biotechnology, and medical device sectors, offering comprehensive quality assurance solutions that accelerate global life‑science innovation. The company specializes in CSV services, GxP audits (GMP, GDP, GLP, GCP, GVP), Veeva integration, and software quality assurance, as well as QMS consulting, CAPA management, SOP authoring, and end‑to‑end audit management. RxCloud’s core value proposition lies in delivering rapid, compliant, and customer‑centric solutions that reduce drug development timelines while ensuring regulatory adherence. Its agile approach enables clients to achieve compliance on the first attempt, distinguishing RxCloud as a trusted partner for quality excellence.
Job Description
Computer Systems Validation Lead with at least 10 years of experience supporting and/or performing all aspects of computer systems validation activities, including development of scalable validation strategies, documents, and performing document reviews.
Requirements
- At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities
- At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
- Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
- Experience with FDA 21 CFR Part 11
- Experience with the validation of Enterprise systems SAP and/or MES system
- Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc
- Knowledge and experience around CSA highly preferred