Clinical Quality Manager

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

Company Description

Renew Biotechnologies develops genomic and epigenomic technologies designed for clinical translation, focusing on tools that can move seamlessly from research to real-world diagnostics. The company is dedicated to bridging the gap between breakthrough discovery and measurable diagnostic impact, enabling more precise and actionable clinical decisions. Team members collaborate across science, engineering, and clinical domains to create platforms that improve patient care and outcomes. Renew Biotechnologies offers an environment where innovative thinkers can see their work directly influence the future of diagnostic medicine.

Role Description

The Clinical Quality Manager is a full-time, on-site role based in Pleasant Grove, UT. This role is responsible for designing, implementing, and maintaining clinical quality systems that support genomic and epigenomic technologies in a regulated environment. Day-to-day responsibilities include developing and updating quality policies and SOPs, overseeing document control, managing deviations, CAPAs, and change controls, and ensuring adherence to relevant regulatory and accreditation standards. The Clinical Quality Manager collaborates with laboratory, clinical, regulatory, and product teams to conduct audits, monitor key quality metrics, and prepare for inspections. This role also leads training initiatives on quality practices, supports continuous improvement projects, and helps translate scientific workflows into compliant, reproducible clinical processes.

Qualifications

• Experience in clinical quality management, including development and oversight of quality systems, SOPs, and document control in laboratory or diagnostic settings.
• Knowledge of relevant regulatory and accreditation frameworks (e.g., CLIA, CAP, ISO 15189, FDA guidance for diagnostics) and demonstrated ability to apply them to clinical workflows.
• Background in molecular diagnostics, genomics, or related life sciences, with the ability to understand and support complex scientific and technical processes.
• Proficiency in quality tools and methodologies such as risk management, root cause analysis, internal auditing, and CAPA management.
• Strong communication, collaboration, and training skills to work effectively with cross-functional teams and promote a culture of quality.
• Bachelor’s degree in a relevant field (e.g., Biology, Biotechnology, Biomedical Engineering, Clinical Laboratory Science); advanced degree or professional certification in quality or regulatory affairs is a plus.
• Prior experience in a clinical laboratory, diagnostic company, or healthcare technology organization is highly beneficial.
• Ability to work on-site in Pleasant Grove, UT, manage multiple priorities, and adapt to a fast-paced, innovation-driven environment.