Manager, Computer Systems Assurance and Validation

The Manager, Computer Systems Assurance and Validation is a subject matter expert (SME) and project owner responsible for leading and executing computer system validation and assurance activities across the organization. Responsibilities Collaborate with Quality Assurance and IS leaders to develop and implement risk-based CSA/CSV strategies and frameworks (CSA, GAMP 5) aligned with global regulatory requirements and best practices. Drive adoption of CSA principles for validation, shifting from traditional CSV to risk-based methodologies. Serve as an SME on validation and compliance; advise stakeholders on software validation and assurance best practices. Maintain awareness of evolving regulatory expectations and update policies/procedures accordingly. Partner with Quality and cross-functional teams to mature validation processes and quality systems (scalable, audit-ready). Own and execute the full validation lifecycle for GxP systems (planning, risk assessment, testing, reporting, periodic review). Execute and/or oversee validation activities; serve as signatory on deliverables where appropriate. Author validation deliverables (system requirements, validation plans, URS, test scripts, traceability matrices, validation reports). Apply risk-based testing strategies and lead system assurance activities (periodic reviews, change management, decommissioning). Requirements Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Engineering, or related field. 8+ years CSV/CSA experience in pharmaceutical/biotech/medical device. Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH guidelines. Demonstrated risk-based validation experience (CSA, GAMP 5). Proven ability to lead validation projects as a cross-functional SME. Strong communication, influence, problem-solving; independent, proactive, ownership-oriented. Preferred Advanced degree. Experience validating both pure software (SaaS/cloud) and embedded/integrated software (lab/manufacturing equipment). Experience improving quality processes/SOPs/validation frameworks in regulated environments. Experience with QMS and electronic validation tools. Experience supporting regulatory inspections/audits. Application instructions Candidates must have current, valid authorization to work in the country where this role is located. #J-18808-Ljbffr Scorpion Therapeutics