QMS Assessment Lead Consultant
About The Position
The QMS Assessment Lead Consultant will support a strategic quality initiative at a manufacturing facility by conducting a comprehensive assessment of the site's Quality Management System, GMP records, system interfaces, batch release processes, and end-to-end materials traceability. The consultant will work 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. The role includes reviewing QMS processes and records, evaluating integrations across manufacturing and quality technology platforms, assessing batch review and release processes, and examining material flows from incoming materials through finished product disposition. The consultant will map risk-ranked findings to applicable regulatory requirements and quality standards, then develop prioritized remediation plans and implementation roadmaps. The role also involves facilitating stakeholder workshops and interviews, conducting on-site assessments, and presenting 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).
- Strong expertise in GMP regulations and compliance.
- Strong expertise in data integrity and ALCOA+ principles.
- Strong expertise in batch review and batch release processes.
- Strong expertise in materials traceability and lot genealogy.
- Strong expertise in CAPA, Change Control, Deviations, and Document Management systems.
- Hands-on experience with ERP/SAP, MES, LIMS, eQMS platforms, and 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.
Responsibilities
- Lead comprehensive assessments of Quality Management Systems 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.
- Review data integrity practices, including ALCOA+ principles, audit trails, and review-by-exception methodologies.
- Conduct end-to-end materials traceability assessments covering incoming materials and warehouse operations, dispensing and kitting, in-process manufacturing, packaging, and 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
