Senior Quality Assurance Specialist

Delve Bio, Inc.; San Francisco (CA); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Performance-based bonus

Comprehensive health insurance

Unlimited PTO

401(k) retirement plan

Professional development allowance

Job summary

Delve Bio, Inc. seeks a Senior Quality Assurance Specialist to operate and mature the QMS within a CLIA/CAP-accredited clinical laboratory. You will own core QA processes, maintain records, and prepare for inspections, while providing training and guidance to staff and peers.

This role offers growth in a fast-paced startup environment, with cross-functional collaboration and a focus on continuous improvement and compliance readiness.

Qualifications

• Bachelor’s degree in life science or related field.
• 3–5+ years QA experience in a CLIA/CAP clinical lab or regulated healthcare setting.
• Knowledge of CLIA (42 CFR 493), CAP checklists, and NYSDOH standards.
• Experience with document control in an electronic QMS and CAPA management.

Responsibilities

• Maintain the eQMS, track quality metrics, and prepare data for management review.
• Own document lifecycle management, including routing, revisions, and distribution.
• Lead investigations, CAPA tracking, and root cause analysis.
• Support internal audits and inspections (CAP, CLIA, NYSDOH).
• Maintain training records and deliver QMS training to staff.
• Track regulatory changes and assist with inspection responses.
• Identify process gaps and drive continuous improvement.

Skills

Attention to detail

Document control

Root cause analysis

Audits & inspections

Regulatory awareness

Communication

Education

Life science degree

Tools

Electronic QMS

Job description

Delve Bio is on a mission to improve patient outcomes and lower healthcare costs by bringing cutting-edge genomic technology to infectious diseases. We are a well-funded biotech company backed by some of the most experienced operators and investors in the industry. Our co-founders are highly experienced researchers, clinicians, and entrepreneurs, including Dr. Matthew Meyerson, MD. PhD (Director of Cancer Genomics at Broad Institute and co-founder of Foundation Medicine) and Dr. Joseph DeRisi, PhD (Professor at the University of California San Francisco and President of the Chan Zuckerberg Biohub). Delve Bio launched its flagship metagenomic next generation sequencing platform Delve Detect in 2024, providing game-changing, infectious disease testing to patients across the US.

About the Role

We’re looking for a Senior Quality Assurance Specialist to help run and mature the Quality Management System under our CLIA/CAP-accredited clinical laboratory structure. Reporting to the Director of Quality Assurance & Regulatory Compliance, you’ll own core QMS processes day to day and play a key role in keeping us inspection-ready as we grow. This role is well suited to someone who works independently, enjoys a broad scope, and wants room to grow in a start-up environment.

What You’ll Do

• QMS Operations: Maintain the eQMS and its records, track quality metrics, and prepare data for management review.
• Document Control: Own the document lifecycle, including routing, revisions, periodic reviews, and distribution. Educate peers on quality requirements and mentor document authors on best practices.
• Nonconformance & CAPA: Lead investigations and root cause analysis, track CAPAs to closure, and trend nonconformances for reporting to the Director.
• Audits & Inspections: Perform internal audits against the audit schedule, support supplier audits, and help prepare for and host CAP, CLIA, and NYSDOH inspections.
• Training: Maintain training records and competency assessments, and deliver QMS training to staff as required.
• Regulatory Support: Track regulatory changes, support license and permit maintenance, and assist with inspection responses.
• Continuous Improvement: Identify process gaps and propose improvements.

What You Bring

• Bachelor’s degree in life science, clinical laboratory science, or a related field.
• 3–5+ years of quality assurance experience in a CLIA/CAP clinical laboratory, diagnostics, or similarly regulated healthcare setting.
• Working knowledge of CLIA (42 CFR 493), CAP checklists, and NYSDOH standards.
• Hands-on experience with document control in an electronic QMS, nonconformance/CAPA management, and root cause analysis.
• Experience conducting or supporting internal audits and participating in external inspections (CAP, CLIA, NYSDOH).
• Strong attention to detail and organizational skills, with the ability to manage multiple priorities in a fast-paced start-up.
• Clear written and verbal communication, including the ability to train and influence staff without formal authority.

Nice to Have

• Molecular or NGS laboratory experience
• Familiarity with FDA Design Controls (21 CFR 820 / QMSR) or IVD/LDT regulatory pathways
• Experience with vendor or biopharma external audits and inspections
• Supplier qualification, equipment and software validation, or complaint handling experience
• ASQ certification (CQA, CQIA, or CMQ/OE), or willingness to pursue one

Compensation & Benefits

• Base salary: 110,00-130,000, depending on experience
• Performance-based annual bonus eligibility
• Comprehensive health insurance, with Delve covering 80% of eligible premiums
• Unlimited paid time off (PTO)
• 401(k) retirement savings plan
• Annual professional development allowance for continuing education, training, and career growth

Delve Bio is an equal opportunity employer. We welcome applicants of all backgrounds and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected characteristic.