Role description
CSV / CSA Lead Computer System Validation & Computer Software Assurance Lead Role Title CSV / CSA Lead (Computer System Validation & Computer Software Assurance Lead) Experience 10-15+ Years Domain Life Sciences / Pharma / Biotechnology / Medical Devices Location Global Delivery / Hybrid Role Summary The CSV / CSA Lead is responsible for leading validation and assurance activities for GxP-regulated computerized systems across laboratory, manufacturing, quality, and enterprise platforms. The role provides strategic and operational leadership for Computer System Validation (CSV), Computer Software Assurance (CSA), Data Integrity, Risk Management, and Regulatory Compliance initiatives. The individual will establish validation strategies, govern validation execution, guide CSA adoption, ensure inspection readiness, and partner with Quality, IT, Manufacturing, Laboratory Operations, and Regulatory stakeholders to deliver compliant and audit-defensible systems. Key Responsibilities CSV / CSA Strategy & Governance • Define and maintain CSV and CSA methodologies, procedures, templates, and governance frameworks. • Drive adoption of risk-based CSA approaches and validation best practices. • Establish standardized validation processes across programs, sites, and business units. • Support development of Validation and CSA Centers of Excellence (CoE). Validation Lifecycle Leadership • Lead the complete validation lifecycle for computerized systems. • Develop and review: • Validation Plans • IQ, OQ, PQ • Validation Summary Reports • Conduct and facilitate risk assessments and gap analyses. • Ensure complete requirements traceability through testing, approvals, and deployment. Computer System Validation (CSV) • Govern CSV lifecycle documentation including requirements, design, testing, defect management, and traceability. • Ensure computerized systems comply with applicable regulations including FDA 21 CFR Part 11 and data integrity requirements. • Collaborate with IT, QA, Quality Systems, Manufacturing, and Laboratory teams to validate GxP-relevant systems. • Serve as CSV subject matter expert during audits and inspections. Computer Software Assurance (CSA) • Apply CSA principles using intended use, critical thinking, and risk-based decision-making. • Define assurance strategies based on system impact and risk. • Implement streamlined testing approaches while maintaining compliance. • Train project teams and stakeholders on CSA methodology and best practices. Regulatory Compliance & Inspection Readiness • Ensure compliance with GxP, FDA 21 CFR Part 11 ,EU Annex 11, GAMP 5, ALCOA+ Data Integrity Principles • Partner with Quality Assurance teams to support inspections and regulatory audits. • Support CAPA, deviation investigations, remediation activities, and inspection responses. Data Integrity Leadership • Act as Data Integrity SME for regulated systems. • Ensure appropriate implementation of Audit Trails, Electronic Signatures, User Access Controls, Traceability Controls, Data Lineage Requirements • Assess and mitigate data integrity and compliance risks across system implementations. Stakeholder & Program Leadership • Work closely with QA, IT and Business stakeholders • Lead validation planning and execution across multiple projects and global teams. • Provide status updates, risk reporting, and compliance metrics to leadership stakeholders. Continuous Improvement & Automation • Identify opportunities to improve validation efficiency through automation and standardized processes. • Support validation tool implementation and process optimization initiatives. • Participate in digital transformation programs involving regulated systems. Required Qualifications Education • Bachelor's or Master's degree in: • Pharmacy • Life Sciences • Biotechnology • Engineering • Computer Science • Related discipline. Experience • 10-15+ years in Life Sciences and GxP-regulated environments. • Experience leading CSV and CSA programs. • Proven experience supporting regulated computerized systems within pharmaceutical, biotechnology, or medical device organizations. • Experience supporting regulatory inspections and audits. Technical Skills Validation & Compliance • Computer System Validation (CSV) • Computer Software Assurance (CSA) • GAMP 5 • FDA 21 CFR Part 11 • EU Annex 11 • ALCOA+ • Risk Assessments • Requirements Traceability • CAPA and Deviation Management • Data Integrity Programs. Platforms & Systems Experience validating one or more of: • LIMS (LabWare, LabVantage, SampleManager) • MES • QMS Platforms (Veeva QMS, MasterControl, TrackWise) • ERP Systems • ELN • CDS • Manufacturing and Laboratory Systems. Validation Tools Exposure to: • ValGenesis • Kneat • HP ALM • Veeva Validation Solutions and related validation toolsets. Leadership Competencies • Strong compliance and quality mindset. • Ability to interpret and apply regulatory guidance. • Cross-functional stakeholder management. • Risk-based decision making. • Executive communication and presentation skills. • Team mentoring and capability development. • Continuous improvement orientation. Preferred Qualifications • Experience establishing or supporting a Validation / CSA CoE. • Experience transitioning organizations from CSV-centric to CSA-aligned approaches. • Experience supporting laboratory informatics, manufacturing execution, or digital transformation initiatives. • Participation in FDA, EMA, MHRA, or other health authority inspections. • Experience with AI system validation or automated validation approaches.
Skills
CSV, LIMS, ERP, Computer Software Assurance
About UST
UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.
