Senior Computer System Validation Specialist

Description Job Title: Senior CSV/ CSA Specialist Department: Information Technology Location: Remote, East Coast Preferred Hours Per Week: 40 Schedule: Days, Monday - Friday SUMMARY The Senior CSV/CSA Specialist leads risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle. The role provides technical leadership in validation strategy, execution, quality review, audit and inspection readiness, while serving as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements. The position also provides mentorship to junior CSV/CSA team members. RESPONSIBILTIES Validation and Assurance Strategy: Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, system upgrades, integrations, infrastructure changes, software changes, and system retirements, Determine appropriate validation or assurance rigor using risk-based principles aligned with GAMP 5, CSA, data integrity, e-record/e-signature, and applicable GxP expectations, Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions, Ensure validation strategies are proportionate to system risk, intended use, business process impact, patient/subject safety, product quality, data integrity, and regulatory impact. CSV/CSA Deliverables: Author, review, or approve validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/design/configuration specifications, IQ/OQ/PQ or functional testing protocols, regression testing, UAT evidence, traceability matrices, validation summary reports, periodic reviews, change impact assessments, data migration, archival, decommissioning, and retirement documentation, Ensure validation documentation is complete, accurate, traceable, reviewable, and inspection-ready, Provide quality and technical review of deliverables prepared by project teams, IT system owners, vendors, and less senior CSV/CSA resources. IT Quality and Compliance Oversight: Provide IT Quality and Compliance oversight for computerized systems, SDLC activities, validation deliverables, change control deliverables, and system lifecycle processes, Support internal audits, external audits, client audits, regulatory inspections, audit responses, CAPAs, deviations, and remediation plans related to computerized systems, Identify compliance gaps, documentation weaknesses, lifecycle risks, and process improvement opportunities, Partner with Quality Assurance to resolve validation-related observations, audit findings, deviations, CAPAs, and inspection commitments. System Lifecycle and Change Support: Support lifecycle activities including procurement, implementation, configuration, validation, operational use, change control, periodic review, incident/deviation support, migration, archival, and retirement, Ensure validated systems remain in a state of control through change assessment, regression testing, periodic review, access/security review, backup/restore review, data integrity review, and documentation maintenance, Provide senior-level review and guidance for GxP IT change controls, impact assessments, validation strategy decisions, test planning, evidence review, and release readiness. Leadership, Mentoring, and Continuous Improvement: Provide technical leadership, coaching, and mentoring to CSV/CSA Specialists and cross-functional project teams, Support development and improvement of validation procedures, forms, templates, guidance documents, training materials, metrics, and operating rhythms, Promote consistent application of risk-based validation, CSA, supplier reliance, testing strategy, and lifecycle documentation practices, Facilitate cross-functional meetings and communications related to validation strategy, compliance expectations, audit readiness, and lifecycle del