QMS Assessment Lead Consultant

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