Job Description We are looking for a remote CSV/GxP consultant to work on a contract through the end of the year. This role is 100% remote but must work 8am - 5pm PST. Lead compliance and validation initiatives for GxP-regulated clinical and R D systems. Conduct and manage Gap Assessments to identify compliance deficiencies, documentation gaps, and validation risks. Develop and oversee remediation plans to address identified gaps and ensure regulatory compliance. Coordinate and manage system validation activities, including: Validation planning Validation documentation development Protocol execution Traceability and compliance reviews Validation reporting Create, review, and maintain SOPs and validation-related documentation. Drive project timelines, milestones, and deliverables to ensure successful completion of compliance initiatives. Facilitate weekly project meetings and provide ongoing status updates to leadership and project stakeholders. Partner with system owners, quality, compliance, and business teams to ensure validation efforts remain on track. Support integration and compliance activities associated with newly acquired business systems. Ensure systems remain compliant with internal SOPs, GxP regulations, and industry best practices. 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.

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•  Proven hands-on experience supporting a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS), as well as non-Veeva systems/platforms (e.g., Egnyte, DOT Compliance, etc.) in regulated environments.
•  Strong expertise in Computer System Validation (CSV), including risk-based validation and end-to-end ownership of validation lifecycle deliverables (URS, FS, IQ/OQ/PQ, TM, etc.) from initiation through closure.
•  Strong knowledge of global GxP regulations (FDA, EMA, ICH), GAMP 5, and their practical application to IT systems, with a focus on maintaining audit and inspection readiness.
•  Demonstrated project management experience, including planning, execution, risk management, and delivery of system implementations and enhancements.
•  Ability to effectively collaborate with cross-functional stakeholders across Quality, Clinical, Regulatory, and IT to gather requirements, drive decisions, and deliver compliant solutions.
•  Experience managing system configurations, releases, integrations, and enhancements across both Veeva and non-Veeva systems, including change controls and impact assessments.
•  Strong understanding of data integrity principles (ALCOA+), system governance, SOP development, and vendor management for GxP applications.
•  Experience performing gap assessments against current SOPs and regulatory requirements and executing the subsequent remediation work would be a plus.