Life Sciences Validation Lead Consultant
We’re Hiring: Life Sciences Validation Lead Consultant (Contract | Remote, U.S.) ViaPoint is seeking an experienced Life Sciences Validation Lead Consultant to support a large-scale, enterprise Clinical, Medical, and Regulatory transformation program within a highly regulated environment. This is a high-impact role at the intersection of technology, compliance, and business transformation, supporting critical systems and programs that enable clinical and regulatory operations at scale. About ViaPoint ViaPoint delivers strategic consulting and program execution services to help organizations turn complex initiatives into measurable outcomes. We specialize in enterprise transformations, M&A integrations, and mission-critical programs across life sciences, financial services, and asset-intensive industries. Our teams operate in fast-paced, high-stakes environments, partnering with global organizations ranging from Fortune 100 enterprises to emerging innovators. The Role You will lead Qualification & Validation (CSV) efforts across multiple platforms supporting Clinical, Medical, and Regulatory functions. This includes driving validation strategy, ensuring compliance, and partnering with cross-functional stakeholders across IT, Quality, and the business. This program includes multiple interconnected systems and workstreams, requiring a structured yet adaptable validation approach across a complex portfolio . Key Responsibilities Lead end-to-end Computer System Validation (CSV) strategy and execution (IQ, OQ, PQ) Define and maintain validation plans, traceability, and compliance documentation Oversee supplier qualification and leverage vendor deliverables where applicable Partner with IT, business, and vendors to ensure compliant system implementation Drive test planning, script execution, and defect management Ensure alignment with GxP, 21 CFR Part 11, and global regulatory standards Support audits, inspections, and compliance reporting Contribute to program-level risk mitigation and governance What We’re Looking For 8+ years of experience in validation, quality, or consulting roles in life sciences Strong experience with GxP systems validation (CSV/CSA) in clinical, regulatory, or medical domains Hands-on experience with IQ/OQ/PQ, URS, RTM, UAT, and validation lifecycle documentation Experience working with enterprise platforms (e.g., clinical systems, regulatory systems, data platforms) Proven ability to operate in complex, global transformation programs Strong stakeholder engagement skills across IT, Quality, and Business leadership Familiarity with vendor-led validation (leveraging IQ/OQ) and internal PQ ownership models is a plus Bachelor’s degree required; advanced degree or certifications (PMP, Lean Six Sigma, etc) preferred Why This Role Be part of a high-visibility, enterprise transformation program Work across multiple critical systems and business functions Influence validation strategy at a program level—not just a single system Collaborate with senior stakeholders in a fast-paced, post-M&A environment Join a nimble, high-performing consulting team at ViaPoint