Senior CSV Specialist - On-Site Quality IT & Compliance

Medial Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, seeks an experienced CSV specialist to lead validation activities for Quality IT systems. You will author and maintain validation documentation, coordinate across IT, vendors, and stakeholders, and drive compliance with FDA/GxP/ISO standards.

The role includes supporting audits and ensuring inspection readiness. The ideal candidate brings 4+ years in CSV and quality systems, with strong cross-functional communication and a track record of leadership in

Qualifications

• 4+ years of experience in Quality Systems, CSV, or regulated IT.
• Strong expertise in CSV lifecycle management.
• Experience with quality documentation authoring and review.
• Knowledge of FDA, GxP, ISO and data integrity requirements.
• Experience managing documentation changes and change control processes.
• Demonstrated leadership in quality and compliance.
• Strong cross-functional communication and stakeholder coordination.

Responsibilities

• Lead and execute CSV activities for Quality IT systems.
• Conduct and maintain validation documentation, including plans, IQ/OQ/PQ, and reports.
• Coordinate validation with IT, system owners, developers, vendors, and stakeholders.
• Provide quality and compliance leadership and SME input on CSV best practices.
• Support audits, regulatory inspections, and findings responses.
• Monitor validation status to ensure audit readiness.
• Stay current with evolving regulatory requirements and best practices.
• Perform system administration and configuration for Quality IT systems.

Skills

CSV lifecycle management

Quality Systems

Documentation authoring

Regulatory compliance

Cross-functional coordination

Stakeholder management

Tools

TrackWise

ETQ

MasterControl

Veeva

Job description

Medial Group in Juncos, Puerto Rico, seeks an experienced CSV specialist to lead validation activities for Quality IT systems. You will author and maintain validation documentation, coordinate across IT, vendors, and stakeholders, and drive compliance with FDA/GxP/ISO standards.

The role includes supporting audits and ensuring inspection readiness. The ideal candidate brings 4+ years in CSV and quality systems, with strong cross-functional communication and a track record of leadership in