Senior QMS & Data Integrity Consultant – On-site PR

ProQualityNetwork; Manatí (PR); On-site; USD 140,000 - 190,000; Full time

Job summary

ProQuality Network seeks a Senior QMS & Data Integrity Consultant to support a comprehensive QMS assessment within a GMP pharmaceutical environment. You will review GMP records, data flows, and batch release processes, identifying gaps and delivering practical, risk-based recommendations.

This hands-on engagement requires working with actual batch records, electronic systems, and cross-functional site teams to ensure compliant operations. On-site support in Puerto Rico is expected.

Qualifications

• Extensive experience with FDA- and/or EU-regulated pharma/biotech/manufacturing environments.

Responsibilities

• Perform end-to-end assessment of the site QMS and GMP processes.
• Evaluate GMP records, deviation handling, CAPA, change control, and document control.
• Assess data integrity with ALCOA+ and data hand-offs across systems.
• Review materials traceability, lot genealogy, and batch release/disposition processes.
• Identify gaps, risks, and single points of failure, including manual reconciliations.
• Develop prioritized remediation recommendations and roadmaps.
• Collaborate with Quality, Manufacturing, IT/Automation and cross-functional teams.

Skills

Quality Management Systems (QMS)

Data Integrity

Analytical skills

Technical writing

Stakeholder management

Tools

ERP

MES

LIMS

eQMS/QMS

Job description

ProQuality Network seeks a Senior QMS & Data Integrity Consultant to support a comprehensive QMS assessment within a GMP pharmaceutical environment. You will review GMP records, data flows, and batch release processes, identifying gaps and delivering practical, risk-based recommendations.

This hands-on engagement requires working with actual batch records, electronic systems, and cross-functional site teams to ensure compliant operations. On-site support in Puerto Rico is expected.