Quality Assurance Supervisor

Based in Lenexa, we are seeking an experienced Quality Assurance professional to support our Clinical Trials and Respiratory Diagnostic Solutions (Healthcare) teams in maintaining compliance with the OneUS QMS and global regulatory standards.

• 401(k)
• Employee assistance program
• Company contributed Health insurance
• Paid time off
• Professional development assistance

• Line management of QA Specialists.
• Oversee clinical trial document control, filing systems (paper/electronic), and eDMS administration.
• Ensure SOPs, templates, and controlled documents are maintained, approved, and distributed in line with QMS requirements.
• Coordinate SOP reviews, training plans, and delivery of QA/GCP training.
• Conduct study file reviews and support internal, supplier, and external audits/inspections.
• Manage CAPAs and Issue Reports, including weekly status reporting.
• Ensure compliance with ICH-GCP, ISO 9001/13485, FDA, and applicable clinical trial regulations.

• Bachelor’s degree or relevant management qualification (preferred).
• 3+ years’ experience in clinical trials or regulated environments, with at least 1 year in a line management role.
• Strong knowledge of ICH-GCP, ISO 13485, and regulatory requirements.
• Experience working in a CRO or clinical service provider environment desirable.
• Highly organised, detail-oriented, and confident leading teams and audits.
• Strong communication skills and proficient in MS Office.

This is an excellent opportunity for a driven QA professional to play a key role in maintaining compliance and quality excellence within a regulated clinical environment. Apply Now