Quality Systems Lead - cGMP & Regulatory Compliance

Kelly; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Kelly in Raleigh, NC is seeking a QA Systems Specialist to support quality assurance systems ensuring cGMP, FDA, and regulatory compliance. You will help maintain inspection readiness by supporting quality systems, change control, audits, quality metrics, and continuous improvement initiatives.

You will work cross-functionally with Manufacturing, Quality Control, Engineering, Supply Chain, and Regulatory Affairs to promote a culture of quality and operational excellence while ensuring products

Qualifications

• Bachelor's degree in a related scientific discipline.
• Minimum of five (5) years of experience in the pharmaceutical, biotechnology, or other cGMP-regulated industry.
• Experience supporting Quality Systems, Quality Assurance, Manufacturing Quality, Validation, or related quality functions.
• Experience participating in regulatory inspections, customer audits, and internal audits.
• Experience with Change Control processes.
• Strong understanding of Quality Systems, Quality Assurance principles, and regulatory compliance.
• Excellent written, verbal, analytical, organizational, and interpersonal communication skills.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook, and PowerPoint).

Responsibilities

• Support and promote a culture of quality and regulatory compliance across the site.
• Ensure compliance with cGMP, FDA, and applicable regulatory requirements.
• Review quality documentation, including change controls, deviations, investigations, risk assessments, and related quality records.
• Support the administration of the Change Control system, including reviews, approvals, KPI tracking, and documentation.
• Collect, analyze, and report Quality Systems metrics for Management Review meetings and Annual Product Reviews (APRs).
• Provide Quality Assurance oversight and guidance for quality systems activities and change control processes.
• Identify and communicate quality risks, compliance concerns, and regulatory issues to management.
• Support customer audits, regulatory inspections, and inspection readiness activities.
• Participate in internal audits, document findings, and assist with corrective action follow-up.
• Support employee training related to quality systems, cGMP requirements, and data integrity.
• Maintain accurate quality records in accordance with company procedures and data integrity requirements.
• Contribute to continuous improvement initiatives that strengthen quality systems and operational performance.
• Perform additional duties as assigned.

Skills

Quality systems experience

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or related

Job description

Kelly in Raleigh, NC is seeking a QA Systems Specialist to support quality assurance systems ensuring cGMP, FDA, and regulatory compliance. You will help maintain inspection readiness by supporting quality systems, change control, audits, quality metrics, and continuous improvement initiatives.

You will work cross-functionally with Manufacturing, Quality Control, Engineering, Supply Chain, and Regulatory Affairs to promote a culture of quality and operational excellence while ensuring products