DescriptionThe CSV Lead is a senior individual contributor and subject matter expert responsible for leading complex, high-risk computerized system validation initiatives across the system lifecycle. Working in close collaboration with the Associate Director, Computerized Systems Validation, the CSV Lead provides technical expertise for validation strategy, planning, execution, and reporting; ensures the quality and completeness of validation deliverables; and promotes consistent application of risk-based, data-integrity, and GxP requirements. The role partners with system owners, operations, IT, Quality, and vendors. The position does not carry routine people-management accountability but may coordinate project teams and provide functional direction.
RequirementsMore specifically, the CSV Lead:- Leads validation workstreams for new GxP computerized systems, upgrades, and system retirements, coordinating activities and deliverables with system owners, business functions, IT, Quality, and vendors.
- Facilitates project initiation and risk-assessment discussions to determine GxP impact, system criticality, validation scope, applicable controls, supplier leverage, and the risk-based validation strategy.
- Develops, reviews, and/or approves by applicable procedures, validation deliverables including validation plans, user requirements specifications, system risk assessments, functional and configuration specifications, test scripts, data migration verification, traceability matrices, deviation records, and validation summary reports.
- Provides technical oversight of validation execution, ensures objective evidence is complete and attributable, and drives the timely resolution of test defects, discrepancies, and documentation gaps before release or closure.
- Performs peer reviews of validation packages and takes accountability for ensuring assigned packages are complete, internally consistent, traceable, inspection-ready, and compliant with applicable policies, SOPs, regulations, and industry practices.
- Assesses vendor validation documentation to determine the extent to which supplier evidence may be leveraged and supports vendor qualification or audit activities when required.
- Leads or provides CSV oversight for lifecycle controls, including change control, periodic review, access and security considerations, backup and restoration, data migration, archival, business continuity, CAPA, and system retirement.
- Acts as team support for complex validation or validation strategy, data integrity, electronic records and signatures, cloud/SaaS, interfaces, emerging technology, and other computerized-system issues.
- Builds effective relationships with system owners and system administrators and provides guidance on their responsibilities for maintaining the validated state of GxP computerized systems.
- Coordinates project-level CSV schedules, dependencies, priorities, risks, and status reporting; identifies resource or timeline constraints and escalates material risks to the Manager, CSV in a timely manner.
- Mentors CSV Analysts and provide day-to-day technical direction and review feedback, shares current industry practices, and supports consistent execution across the CSV team.
- Develops and delivers CSV training for project teams (system owners, business SMEs, testers) as required by projects or process changes.
- Contribute to the creation and revision of CSV policies, SOPs, templates, tools, metrics, and process-improvement initiatives, and supports implementation of approved changes.
- Maintains current knowledge of applicable computerized-system regulations, guidance, industry standards, and evolving technologies, including cloud services, connected devices, automation, and artificial intelligence, and recommends appropriate updates to CSV practices.
- Supports internal audits, vendor audits, client audits and requests for information, and regulatory inspections by preparing evidence, responding to questions, and supporting remediation activities.
As a CSV Lead, you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Work location
The successful candidate for this position is given to work remotely anywhere in Argentina. 
