QMS Assessment Lead Consultant

QRC Group; Northern (KY); Hybrid; USD 130,000 - 180,000; Full time

Job summary

QRC Group in Puerto Rico is seeking an experienced Quality Management System (QMS) Assessment Lead Consultant to support a strategic quality initiative at a manufacturing facility. This engagement will perform a comprehensive assessment of the site's QMS, GMP records, system interfaces, batch release processes, and end-to-end materials traceability.

The successful candidate will work with Quality, Manufacturing, and IT stakeholders to identify risks, evaluate data integrity practices, map

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Pharmaceutical Sciences, or related field.
• 8+ years in pharmaceutical/biotech/biologics or medical device manufacturing.
• Experience conducting gap assessments, compliance audits, or quality system reviews.

Responsibilities

• Lead QMS assessments within regulated GMP environments.
• Evaluate GMP record management and archival processes.
• Assess ERP, MES, LIMS, eQMS interfaces and data flows.
• Review data integrity practices including ALCOA+ and audit trails.
• Conduct end-to-end materials traceability assessments.
• Identify gaps and remediations aligned with FDA, EU GMP, ICH.
• Develop prioritized remediation plans and roadmaps.
• Facilitate workshops and present findings to leadership.

Skills

QMS knowledge

GMP compliance

Data integrity

ALCOA+ principles

Batch release

Materials traceability

Regulatory audit support

Education

Bachelor's degree in Engineering, Life Sciences, or related discipline

Tools

ERP/SAP

MES

LIMS

eQMS platforms

Automation systems

Job description

Manati, Puerto Rico | Posted on 10/14/2026

We are seeking an experienced Quality Management System (QMS) Assessment Lead Consultant to support a strategic quality initiative at a manufacturing facility. This engagement focuses on performing a comprehensive assessment of the site's Quality Management System, GMP records, system interfaces, batch release processes, and end-to-end materials traceability.

The successful candidate will work closely with Quality, Manufacturing, and IT stakeholders to identify compliance risks, evaluate data integrity practices, assess material traceability, and develop practical recommendations to strengthen quality systems and release decision processes.

Key Responsibilities

• Lead comprehensive assessments of Quality Management Systems (QMS) within regulated GMP environments.
  
• Evaluate GMP record management processes, including document generation, review, approval, retention, and archival.
  
• Assess system integrations and interfaces across ERP, MES, LIMS, eQMS, warehouse management, and automation platforms.
  
• Perform detailed reviews of data integrity practices, including ALCOA+ principles, audit trails, and review-by-exception methodologies.
  
• Conduct end-to-end materials traceability assessments, including:
  
• Incoming materials and warehouse operations
  
• Dispensing and kitting processes
  
• In-process manufacturing activities
  
• Packaging operations
  
• Finished product disposition and release
  
• Evaluate batch review and batch release processes for robustness, compliance, and operational effectiveness.
  
• Identify gaps, risks, and opportunities for improvement against FDA, EU GMP, ICH, and corporate quality standards.
  
• Develop risk-ranked findings and map observations to applicable regulatory requirements and quality standards.
  
• Create prioritized remediation plans, implementation roadmaps, and practical recommendations.
  
• Facilitate workshops, interviews, and on-site assessments with cross-functional stakeholders.
  
• Deliver executive presentations and communicate findings to senior leadership.
  

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, Pharmaceutical Sciences, or a related discipline.
  
• Minimum 8+ years of experience in pharmaceutical, biotechnology, biologics, or medical device manufacturing environments.
  

Strong expertise in:

• Quality Management Systems (QMS)
  
• GMP regulations and compliance
  
• Data Integrity and ALCOA+ principles
  
• Batch review and batch release processes
  
• Materials traceability and lot genealogy
  
• CAPA, Change Control, Deviations, and Document Management systems
  

Hands-on experience with systems such as:

• ERP / SAP
  
• MES
  
• LIMS
  
• eQMS platforms
  
• Manufacturing and Automation systems
  
• Demonstrated experience conducting gap assessments, compliance audits, or quality system reviews.
  
• Strong analytical, facilitation, and technical writing skills.
  
• Ability to work effectively in a highly regulated manufacturing environment