Senior Clinical Quality Lead – Genomics Diagnostics

Renew Biotechnologies; Pleasant Grove (UT); On-site; USD 110,000 - 165,000; Full time

Job summary

Renew Biotechnologies is seeking a Clinical Quality Manager to design and maintain quality systems for genomic diagnostics in a fast-paced, onsite setting in Pleasant Grove, UT. You will drive policy development, SOP management, and document control while coordinating audits and CAPA processes with clinical, regulatory, and product teams.

The role requires deep knowledge of CLIA, CAP, ISO 15189, and FDA guidance, plus hands-on experience in molecular diagnostics.

Qualifications

• Experience building and overseeing quality systems, SOPs, and document control.
• Familiarity with CLIA, CAP, ISO 15189 and FDA guidance for diagnostics.
• Background in molecular diagnostics or related life sciences is preferred.

Responsibilities

• Design, implement, and maintain clinical quality systems for regulated workflows.
• Develop and update quality policies and SOPs; manage document control.
• Lead audits, monitor quality metrics, and prepare inspections.
• Oversee deviations, CAPAs, and change controls; ensure regulatory alignment.
• Lead training initiatives and drive continuous improvement across teams.

Skills

Quality systems development

Regulatory compliance

Cross-functional collaboration

Training and coaching

SOP writing

Document control

Education

Bachelor’s degree in Biology/ Biotechnology/ Biomedical Engineering/ Clinical Lab Science

Advanced degree or professional certification in quality/regulatory affairs (plus)

Tools

QMS experience

CAPA tools

Risk management

Internal auditing

Job description

Renew Biotechnologies is seeking a Clinical Quality Manager to design and maintain quality systems for genomic diagnostics in a fast-paced, onsite setting in Pleasant Grove, UT. You will drive policy development, SOP management, and document control while coordinating audits and CAPA processes with clinical, regulatory, and product teams.

The role requires deep knowledge of CLIA, CAP, ISO 15189, and FDA guidance, plus hands-on experience in molecular diagnostics.