Manager, Quality Assurance, Scientific Operations

Location: San Carlos, California, United States; office or hybrid office environment

Compensation: $55 USD

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Own quality management across Sample Management and Sample Operations in partnership with the hirify.global QA team.
• Maintain and improve the Quality Management System, QA/QC processes, compliance structures, and quality workflows.
• Lead root cause analysis and CAPA processes for deviations, non-conformances, and audit findings.
• Conduct spot-checks and routine audits of lab run packages, sample logs, and experimental records.
• Manage SOPs, technical protocols, equipment calibration logs, safety documents, version control, and review cycles.
• Maintain audit-ready documentation and enforce data-logging standards for raw data, metadata, and reports in LIMS.

Requirements

• B.S. or M.S. in Life Sciences or a related field.
• 5+ years of Quality Assurance or Quality Management experience in biotechnology, clinical laboratories, or diagnostics.
• Hands-on CAP compliance experience and familiarity with CAP inspection processes and checklist requirements.
• Familiarity with biobank regulations and certification standards such as ISBER or BBMRI.
• Strong understanding of GLP, GxP, ISO 9001, and ISO 17025 frameworks in laboratory settings.
• Experience supporting or leading internal and external audits, corrective and preventive actions, SOP drafting, and quality documentation.

Nice to have

• Experience at an early-stage or startup company building or significantly maturing QA/QC systems.

Culture & Benefits

• Office or hybrid work environment with occasional work outside normal business hours for project timelines and coordination.
• Medical, dental, vision, life, and disability benefits for eligible employees and dependents.
• 401(k) with company match, paid time off, and company holidays.
• Wellness, work-life, commuter, fertility care, pregnancy, and baby bonding benefits.