Quality Systems Improvement Specialist

Laboratoire Guerbet•Raleigh, IL

About The Position

The Quality Systems Improvement Specialist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. This role focuses on strengthening and improving the Quality Management System (QMS) by translating regulatory requirements, internal assessments, and operational insights into practical, sustainable enhancements. Working cross-functionally with Quality, Operations, and other stakeholders, the Specialist ensures quality systems are robust, compliant, and effectively embedded across the organization. It is a hands-on position dedicated to implementing improvements and driving long-term quality system effectiveness rather than providing oversight alone. THIS ROLE IS A CONTRACT ROLE THAT WILL LAST 18-24 MONTHS AND WILL BE ELIGIBLE FOR GUERBET BENEFITS.

Requirements

Bachelor’s degree in Life Sciences, Quality, Engineering, or a related field (or equivalent combination of education and experience).
10+ years of experience in pharmaceutical Quality Assurance, Quality Systems, or Quality Compliance within a GMP-regulated environment.
Demonstrated experience contributing to Quality Management System (QMS) improvements or transformation initiatives.
Strong expertise in root cause analysis, CAPA systems, and quality governance frameworks.
Solid understanding of 21 CFR Parts 210 and 211 and general GMP regulatory expectations.
Practical experience applying Quality Risk Management (ICH Q9) principles and risk-based decision-making.

Nice To Haves

Experience working in sterile manufacturing or terminal sterilization environments.
Knowledge of global regulatory expectations for sterile products (e.g., FDA, EMA, PIC/S).
Experience supporting regulatory inspections, audit readiness, or quality system remediation efforts.

Responsibilities

Lead and actively contribute to the implementation of CAPAs and quality system improvements originating from internal assessments and evaluations.
Translate regulatory expectations and quality commitments into clear, practical actions across the organization.
Work with cross-functional teams to ensure corrective and preventive actions are fully implemented and embedded into routine processes and governance structures.
Monitor progress of improvement initiatives, identify barriers, and facilitate resolution with relevant stakeholders.
Verify effectiveness of implemented actions through structured follow-up, data analysis, and objective evidence.
Contribute to the continuous improvement and integration of core QMS elements, including change control, deviations, CAPA management, internal audits, and document management systems.
Collaborate with stakeholders to ensure QMS processes remain robust, practical, and aligned with regulatory expectations and company policies.
Support the development and maintenance of governance structures that enable accountability, effective decision-making, and sustainable compliance.
Performs other duties as assigned by management