Sr. Quality Applications Specialist

Medial Group; Juncos (PR); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CSV lifecycle management

Quality Systems

Documentation authoring

Regulatory compliance

Cross-functional coordination

Stakeholder management

Outils

TrackWise

ETQ

MasterControl

Veeva

Description du poste

Juncos, Puerto Rico

• Lead and execute Computer System Validation (CSV) activities for Quality Information Technology systems in compliance with FDA, GxP, ISO, and global regulatory requirements.
• Conduct and maintain formal validation documentation, including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols and reports, and supporting SOPs.
• Coordinate validation efforts with IT, system owners, developers, vendors, and operational users, including global stakeholders when applicable.
• Provide quality and compliance leadership to peers, serving as a subject matter expert on CSV best practices and regulatory expectations.
• Support and assess documentation and system changes through formal change control and impact assessments.
• Identify current and future regulatory requirements for computerized systems and recommend strategies to ensure ongoing compliance.
• Perform system administration and configuration for Quality IT systems (e.g., QMS, CAPA, Document Control, Training, Complaints).
• Monitor, track, and report validation status to ensure audit and inspection readiness.
• Stay current with evolving regulatory requirements, audit trends, and industry best practices related to computerized systems and data integrity.
• Support internal and external audits and regulatory inspections, including preparation and response to findings.

*Other duties may be assigned*

Requirements

• 4+ years of experience in Quality Systems, Computer System Validation (CSV), or regulated IT environments.
• Strong expertise in Computer System Validation (CSV) lifecycle management.
• Proven experience with quality documentation authoring and review, including validation and SOP documentation.
• Knowledge of FDA, GxP, ISO, and data integrity requirements.
• Experience managing documentation changes and change control processes.
• Demonstrated quality and compliance leadership and ability to influence peers.
• Strong cross-functional communication and stakeholder coordination skills.

Preferred / Nice to Have

• Experience in medical device and/or pharmaceutical manufacturing environments.
• Experience supporting global or multi-site quality systems.
• Familiarity with electronic Quality Management Systems (QMS) such as TrackWise, ETQ, MasterControl, or Veeva.
• Experience supporting regulatory audits and inspections related to computerized systems.

*Willing to work 100% on-Site in Juncos, PR.*