Quality Systems Lead — Audit Readiness & Compliance

Guerbet; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet in Raleigh, NC seeks a QA Systems Specialist to uphold cGMP standards and regulatory compliance while supporting quality systems. You will collaborate with Manufacturing, Quality Control, Regulatory Affairs, and other functions to maintain inspection readiness.

Responsibilities include reviewing change controls, deviations, investigations, data analysis, and KPI tracking; supporting annual product reviews and management reviews; and guiding QA for change controls and quality systems.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or another scientific discipline.
• Minimum of 5 years of experience in the pharmaceutical, biotechnology, or other cGMP-regulated industry.
• Experience supporting Quality Systems, Quality Operations, Validation, Manufacturing Quality, or related quality functions.
• Experience participating in regulatory inspections, customer audits, and internal audit programs.
• Experience with Change Control processes as an initiator, reviewer, or Quality approver.
• Demonstrated knowledge of Quality Assurance principles, quality systems, and regulatory compliance within a regulated environment.
• Strong written, verbal, and interpersonal communication skills with the ability to collaborate effectively across functional areas.
• Strong organizational, analytical, problem-solving, and decision-making skills.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.

Responsibilities

• Promote and foster a culture of quality throughout the site by ensuring adherence to quality principles, regulatory requirements, and company standards.
• Partner with cross-functional teams and site leadership to support Quality Systems activities and drive compliance-focused decision-making.
• Collaborate with Global Regulatory Affairs to ensure site compliance with global product registrations.
• Ensure compliance with applicable FDA, cGMP, international regulatory requirements, and company quality systems.
• Review and assess quality-related documentation, including Change Controls, risk assessments, deviations, investigations, and records supporting changes to utilities, manufacturing, and Quality Control operations.
• Support management of the Change Control system through review and approval of change controls, KPI tracking, and system administration.
• Support Management Review meetings through data collection, analysis, and presentation of quality system metrics to site leadership.
• Compile and analyze Quality Systems data for Annual Product Reviews and other site quality reporting requirements.
• Provide Quality Assurance oversight and guidance for change controls and quality system activities.
• Identify, assess, elevate, and communicate quality risks, compliance concerns, and regulatory issues to site leadership in a timely manner.
• Support customer audits, regulatory inspections, and audit readiness activities by providing documentation, responses, and Quality Assurance expertise.

Skills

QA principles

Regulatory compliance

Cross-functional collaboration

Communication skills

Analytical skills

Microsoft Office

Education

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or another scientific discipline

Tools

eQMS

Change Control Systems

Document Control

CAPA tools

Job description

Guerbet in Raleigh, NC seeks a QA Systems Specialist to uphold cGMP standards and regulatory compliance while supporting quality systems. You will collaborate with Manufacturing, Quality Control, Regulatory Affairs, and other functions to maintain inspection readiness.

Responsibilities include reviewing change controls, deviations, investigations, data analysis, and KPI tracking; supporting annual product reviews and management reviews; and guiding QA for change controls and quality systems.