Senior QMS & Data Integrity Consultant – GMP Systems & Batch Release

Location: Puerto Rico – On-Site Support Required

Industry: Pharmaceutical / Biopharmaceutical Manufacturing

Project Type: Consulting Engagement

Position Summary

ProQuality Network is seeking a highly experienced Senior QMS & Data Integrity Consultant to support a comprehensive, end-to-end Quality Management System (QMS) assessment within a GMP-regulated pharmaceutical manufacturing environment.

The selected consultant will perform a hands-on evaluation of quality systems, GMP records, computerized system interfaces, materials traceability, and batch disposition/release processes. This role requires a senior-level Quality professional capable of evaluating how GMP information flows across manufacturing and quality systems, identifying compliance and operational gaps, and developing practical, risk-based recommendations.

This is not solely a desktop or procedural review. The consultant must be comfortable working directly with actual batch records, electronic systems, paper/hybrid records, and cross-functional site teams to evaluate how processes operate in practice. RFP_QMS_Assessment_V1

Key Responsibilities

• Perform an end-to-end assessment of the site Quality Management System (QMS) and supporting GMP processes.
• Evaluate GMP record creation, review, approval, reconciliation, and archival processes.
• Assess key QMS elements, including Deviations, CAPA, Change Control, Document Control, Complaint Handling, and Product Quality Review.
• Review electronic and paper/hybrid GMP records and evaluate interfaces across systems such as ERP/MRP, MES, LIMS, QMS/eQMS, warehouse management, and equipment/automation systems.
• Assess Data Integrity and ALCOA+ compliance, including audit trails, data hand-offs, manual transcription, reconciliation, and review-by-exception practices.
• Evaluate end-to-end materials traceability and lot genealogy, from incoming materials through manufacturing, packaging, and finished-product disposition.
• Assess forward and backward traceability of materials, components, equipment, records, and finished lots.
• Evaluate the robustness of batch record review, batch disposition, and product release processes.
• Identify gaps, weaknesses, single points of failure, conflicting records, and areas dependent on manual reconciliation.
• Conduct risk-based gap assessments against applicable GMP and regulatory requirements.
• Develop practical, prioritized recommendations, including quick wins and medium- and long-term remediation strategies.
• Collaborate directly with Quality, Manufacturing, IT/Automation, and other cross-functional stakeholders.
• Support development of current-state process maps, gap assessments, remediation roadmaps, and executive-level findings/readouts. RFP_QMS_Assessment_V1

Required Qualifications

• Extensive experience in Quality Management Systems (QMS) within FDA- and/or EU-regulated pharmaceutical, biotechnology, biologics, or medical device manufacturing environments.
• Demonstrated hands-on experience with GMP records management, Data Integrity, and batch release/disposition processes.
• Strong understanding of materials traceability and lot genealogy within GMP manufacturing operations.
• Experience evaluating or working across computerized systems such as ERP, MES, LIMS, eQMS/QMS, warehouse management, and manufacturing/automation systems.
• Strong knowledge of GMP requirements, ALCOA+ principles, and applicable FDA and EU GMP expectations.
• Experience with quality systems including Deviations, CAPA, Change Control, Document Control, and Product Quality Review.
• Ability to identify compliance and operational risks and translate findings into practical, implementable remediation actions.
• Strong analytical, technical writing, communication, and stakeholder-management skills.
• Ability to work independently and interact effectively with senior Quality leadership and cross-functional technical teams.
• Availability to provide on-site support in Puerto Rico as required. RFP_QMS_Assessment_V1

Highly Desired Experience

Previous experience performing QMS assessments, compliance gap assessments, data integrity reviews, batch-release assessments, or remediation programs in regulated manufacturing environments is highly desirable.

Experience physically tracing batch records and material flows across multiple electronic systems and paper/hybrid records is particularly valuable for this engagement.

Regulatory / Technical Knowledge

Candidates should have strong working knowledge of applicable pharmaceutical quality and GMP frameworks, including:

21 CFR Parts 210 & 211 | EU GMP | ICH Q7/Q9/Q10 | Data Integrity / ALCOA+ | GMP Records | QMS | Batch Release & Disposition | Materials Traceability | Lot Genealogy | Deviations | CAPA | Change Control | ERP | MES | LIMS | eQMS