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Tier-1 employer and metro location increase competition despite niche CSV specialization.
Role requires specialized GxP/CSV regulatory experience, limiting cross-industry transferability.
Mandatory 8+ years CSV, regulatory expertise, and leadership create high shortlisting rigor.
Lead validation strategy and governance for GxP-regulated applications, ensuring compliance with SOPs, regulations, and industry standards.
Own end-to-end validation activities including authoring validation deliverables and managing RTM traceability to ensure inspection readiness and audit support.
Lead and mentor a validation team, partnering cross-functionally to drive compliant, timely delivery and continuous improvement initiatives.
Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
8+ years experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated environments.
3+ years experience leading validation teams, programs, or quality compliance initiatives.
Strong knowledge of GxP regulations, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Experienced in leading validation of global, enterprise-scale digital platforms in regulated environments.
Demonstrated ability to manage full validation lifecycle including risk-based strategies, compliance documentation, and traceability matrices.
Skilled at collaborating with Product, Business, Quality, Regulatory, and Technology stakeholders to deliver quality-driven solutions under inspection-ready conditions.