Senior QA Leader: Regulatory Compliance & CAPA

Baylor Genetics; Houston, Northern (TX, KY); Hybrid; USD 100,000 - 150,000; Full time

Job summary

Baylor Genetics is seeking a Senior QA Specialist to act as a Quality SME and trusted partner across Laboratory Operations, Clinical, Regulatory, IT, Product, and Customer Experience. The role focuses on identifying systemic quality risks, guiding stakeholders, and translating quality data into actionable improvements that enhance patient safety and regulatory compliance.

The position requires deep knowledge of CLIA, CAP, NYS/FDA standards, and experience with audits, CAPA, and quality metrics.

Qualifications

• Master’s degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or related field with 3 years of quality experience in a clinical laboratory setting or equivalent.
• Or Bachelor’s degree in Life Sciences, Biological Sciences, Medical Technology, Quality, Healthcare, or related field with 6 years of quality experience in a clinical laboratory setting or equivalent combination of experience.

Responsibilities

• Independently execute and oversee assigned elements of the Quality Management System.
• Lead complex and cross-functional quality event investigations, including nonconformances, deviations, errors, complaints, and other quality events.
• Develop and manage CAPAs that address systemic causes and prevent recurrence.
• Monitor quality event trends and identify recurring or systemic issues requiring escalation.
• Coordinate responses to audit findings and monitor corrective actions through closure.

Skills

Quality management

Root cause analysis

CAPA management

Audits

Cross-functional collaboration

Data analysis

SOP writing

MS Office

Smartsheet

SharePoint

Education

Master's degree in Life Sciences

Bachelor's degree in Life Sciences

Tools

MS Word

Excel

Outlook

PowerPoint

Smartsheet

SharePoint

Job description

Baylor Genetics is seeking a Senior QA Specialist to act as a Quality SME and trusted partner across Laboratory Operations, Clinical, Regulatory, IT, Product, and Customer Experience. The role focuses on identifying systemic quality risks, guiding stakeholders, and translating quality data into actionable improvements that enhance patient safety and regulatory compliance.

The position requires deep knowledge of CLIA, CAP, NYS/FDA standards, and experience with audits, CAPA, and quality metrics.