Remote - CSV/GxP Consultant

We are seeking an experienced CSV / GxP Validation Consultant with a strong focus on clinical systems and GCP (Good Clinical Practice) compliance. This role will lead and support validation activities for clinical platforms while partnering closely with Quality, IT, and business stakeholders. Experience working within small to mid-size, clinical-stage biotech environments is highly preferred. this role can work 100% remote although we are looking for someone to work 8am - 5pm PST hours., * Lead and execute Computer System Validation (CSV) activities for clinical systems, regulatory and quality systems in regulated GCP environments

• Own validation deliverables across the full lifecycle, including:

• Validation plans

• Risk assessments

• Requirements and specifications

• Test execution and traceability

• Validation reports and approvals

• Serve as the project lead for validation initiatives, managing timelines, documentation, and cross-functional alignment

• Ensure compliance with GCP regulations, with exposure to additional GxP areas such as clinical systems, regulatory and quality systems as applicable

Partner with internal teams to support system implementations, upgrades, and ongoing compliance activities

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global’s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

• 5-10+ Strong hands-on experience in CSV within clinical systems - with modern CSV practices

• Deep understanding of GCP requirements and clinical validation practices

• Experience validating clinical systems such as Veeva Vault EDC, Veeva Vault CTMS, Veeva Vault eTMF

• Exposure to regulatory information management solutions, including: Veeva Vault RIM Registrations and Veeva Vault RIM Submissions

• Hands-on experience with Veeva quality platforms, including: Veeva Vault QualityDocs, Veeva Vault Training, Veeva Vault QMS

• Demonstrated ability to lead validation projects, not just support execution

• Experience working within small to mid-size, clinical-stage biotech companies (e.g., similar to Tarsus)

• Comfortable operating in lean environments and owning deliverables end-to-end

Strong stakeholder communication, project management skills, and work cross functionally * Experience supporting rapid growth or scaling organizations

• Support inspection readiness, audits, and remediation efforts when needed

Analytics & Reporting

• Experience with clinical and regulatory analytics tools, including:

• JReview

• SAS Life Science Analytics Framework (LSAF)

• Certara WinNonlin

• Kayentis ePRO (clinical data capture and patient-reported outcomes)