Lead CSV/CSA Lead

Rochester Regional Health

8d•$130,000 - $155,000•Remote

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. The position translates CSV/CSA governance requirements into practical, risk-based, and inspection-ready project execution.

Requirements

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field OR Equivalent combination of education and relevant experience
7+ years experience in CSV/CSA, GxP IT quality, validation, quality systems, software assurance, or regulated system lifecycle experience

Nice To Haves

Strong knowledge of CSV, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, e-records/e-signatures, validation lifecycle deliverables, and risk-based validation practices.
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.
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.

Responsibilities

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.
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.
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 audits, client audits, supplier audits, regulatory inspections, audit responses, deviations, CAPAs, and remediation plans related to validated computerized systems.
Provide SME-level guidance to project teams and stakeholders on validation documentation, evidence expectations, and inspection-readiness practices.
Ensure validated systems remain 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 proper 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 meetings and communication related to validation strategy, compliance expectations, lifecycle responsibilities, and audit readiness.