Lead CSV/CSA Lead

Job Title : Senior CSV/ CSA Specialist Department : Information Technology Location: Remote, East Coast Preferred Hours Per Week: 40 Schedule: Days, Monday – Friday SUMMARY The Lead CSV/CSA Specialist serves as the primary validation lead for complex GxP computerized system projects, overseeing validation planning, execution, documentation, and lifecycle activities.

The role partners closely with IT and Quality Assurance, mentors junior team members, and ensures systems comply with internal procedures and regulatory expectations. The position translates CSV/CSA governance requirements into practical, risk-based, and inspection-ready project execution.

RESPONSIBILTIES Validation Leadership and Oversight: Lead validation and assurance planning for assigned new systems, upgrades, integrations, infrastructure changes, software changes, configuration changes, and system retirements, Serve as lead validator or CSV/CSA project lead throughout the system lifecycle and coordinate validation activities across project teams, IT system owners, Quality Assurance, vendors, and business stakeholders, Apply risk-based validation and CSA principles to determine appropriate deliverables, testing rigor, supplier reliance, evidence expectations, and approval strategy.

CSV/CSA Deliverables and Review: Author, review, approve, or oversee validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/configuration/design specifications, test protocols, traceability matrices, validation summary reports, periodic reviews, and change impact assessments, Ensure documentation is complete, accurate, traceable, reviewable, properly approved, and inspection-ready.

Oversee defect management, issue resolution, testing evidence compilation, and validation summary documentation. Regulatory, Quality, and Audit Support: Ensure assigned systems and changes meet applicable GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, electronic reco