Lead CSV/CSA Specialist
About The Position
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. It translates CSV/CSA governance requirements into practical, risk-based, inspection-ready project execution. The position leads validation and assurance activities for system implementations and changes throughout the system lifecycle; oversees validation documentation, testing evidence, issue resolution, and inspection readiness; supports audits and regulatory inspections; and helps maintain validated systems in a state of control. The role also mentors CSV/CSA Specialists and contributes to improvements in procedures, templates, training, metrics, and portfolio practices. This is a remote role, with East Coast candidates preferred. The listed schedule is 40 hours per week, days, Monday through Friday. The position is described as sedentary and primarily office-based.
Requirements
- Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field, or an equivalent combination of education and relevant experience.
- At least 7 years of experience in CSV/CSA, GxP IT quality, validation, quality systems, software assurance, or regulated system lifecycle work.
- Strong knowledge of CSV, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, electronic records/electronic signatures, validation lifecycle deliverables, and risk-based validation practices.
- Ability to lead complex validation work across multiple stakeholders and coordinate review, approval, testing, evidence, and delivery activities.
- Strong technical writing, documentation review, facilitation, mentoring, stakeholder engagement, analytical, and problem-solving skills.
- Ability to work independently, prioritize competing assignments, and escalate risks, blockers, resource constraints, or unclear ownership.
Nice To Haves
- Experience leading validation strategy and deliverable execution for complex laboratory, quality, clinical, enterprise, infrastructure, integration, cloud/SaaS, or data systems.
- Experience supporting audits, inspections, deviations, CAPAs, remediation activities, supplier assessments, and change control processes.
Responsibilities
- Lead validation and assurance planning for assigned new systems, upgrades, integrations, infrastructure changes, software and configuration changes, and system retirements.
- Serve as lead validator or CSV/CSA project lead throughout the system lifecycle and coordinate work across project teams, IT system owners, Quality Assurance, vendors, and business stakeholders.
- Apply risk-based validation and CSA principles to determine deliverables, testing rigor, supplier reliance, evidence expectations, and approval strategy.
- Author, review, approve, or oversee validation lifecycle deliverables, including risk assessments, validation or assurance plans, URS, 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, and validation summary documentation.
- Ensure assigned systems and changes meet applicable GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, electronic records/electronic signatures, internal procedure, and quality expectations.
- Support internal, client, and supplier audits; regulatory inspections; audit responses; deviations; CAPAs; and remediation plans related to validated computerized systems.
- Provide subject-matter guidance on validation documentation, evidence expectations, and inspection-readiness practices.
- Maintain validated systems in a state of control through change impact assessments, regression testing, periodic reviews, access/security reviews, backup/restore reviews, data integrity reviews, and lifecycle documentation maintenance.
- Support integration of validation, change control, release readiness, configuration management, supplier management, and SDLC quality expectations.
- Lead validation impact assessment and test strategy decisions for assigned GxP IT changes.
- Mentor CSV/CSA Specialists and other project contributors on validation principles, documentation quality, evidence expectations, and risk-based decision-making.
- Support improvement of SOPs, forms, templates, guidance, training materials, metrics, operating rhythms, and portfolio practices.
- Facilitate cross-functional communication and meetings related to validation strategy, compliance expectations, lifecycle responsibilities, and audit readiness.
- Undertake other duties reasonably required and commensurate with the skills, experience, and responsibility level of the role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
