Clinical Genomics QA & Regulatory Architect

SeqMatic, LLC; Fremont (CA); On-site; USD 125,000 - 145,000; Full time

Job summary

SeqMatic, LLC in Fremont, California, is seeking a Clinical Laboratory QA & Regulatory Specialist (Individual Contributor) to architect and scale the quality and regulatory framework for NGS-based LDTs. This in-house, full-time role combines hands-on execution with strategic program development in a fast-growing biotech setting.

You will lead CLIA/CAP registrations, write SOPs, manage QMS, and collaborate with bioinformatics teams to ensure data integrity and compliant pipelines, audits, and

Qualifications

• Bachelor's or Master's degree in Molecular Biology, Genetics, Bioinformatics, or a closely related life science discipline.
• 3+ years of direct experience managing regulatory affairs, quality assurance, or high-complexity clinical operations within an active CLIA-certified and CAP-accredited molecular diagnostics laboratory.
• Proven, hands-on familiarity with next-generation sequencing (NGS) workflows, wet lab platforms (e.g., Illumina), genomic data integrity standards, and clinical variant classification (ACMG/AMP guidelines).
• Thorough operational understanding of 42 CFR Part 493 (CLIA), CAP general and molecular checklists, California clinical laboratory laws, and the implications of the FDA's Final Rule on LDT oversight.
• Proven capability to build processes where none exist. Must be completely self-directed, comfortable navigating ambiguity, and eager to physically write the protocols and SOPs rather than delegating them.
• Exceptional interpersonal and technical writing skills; able to translate highly complex legal and regulatory mandates into actionable items for scientists and engineers.

Responsibilities

• Establish Compliance Infrastructure: Lead initial facility registrations and programmatic requirements to secure and maintain CLIA certification, CAP accreditation, and California state clinical laboratory licenses from the ground up.
• LDT Validation Documentation: Author, organize, and compile comprehensive analytical and clinical validation packages for high-complexity NGS assays, ensuring compliance with CLIA/CAP guidelines and state frameworks.
• Navigate Evolving FDA Frameworks: Interpret, strategize, and execute compliance workflows matching the FDA's multi-phase oversight framework for Laboratory Developed Tests, including adverse event reporting, corrections, and future premarket expectations.
• Own and Mature the QMS: Design, implement, and maintain a lean, scalable Quality Management System (QMS). Responsibilities include writing core SOPs, managing document control, overseeing proficiency testing (PT), coordinating training logs, and tracking CAPAs and non-conformances.
• Bioinformatics & LIMS Collaboration: Partner closely with our customers and our in-house computational biology teams to document and validate clinical bioinformatics pipelines, data integrity protocols, variant filtering parameters, and LIMS workflows.
• Inspection Readiness: Act as the primary technical point of contact for external audits, California CDPH inspections, and laboratory audits.

Skills

NGS workflows

Illumina platforms

Genomic data integrity

ACMG/AMP guidance

42 CFR Part 493 CLIA

CAP checklists

California clinical lab laws

FDA LDT oversight

Startup mentality

Technical writing

Education

Bachelor's or Master's in Molecular Biology / Genetics / Bioinformatics

Job description

SeqMatic, LLC in Fremont, California, is seeking a Clinical Laboratory QA & Regulatory Specialist (Individual Contributor) to architect and scale the quality and regulatory framework for NGS-based LDTs. This in-house, full-time role combines hands-on execution with strategic program development in a fast-growing biotech setting.

You will lead CLIA/CAP registrations, write SOPs, manage QMS, and collaborate with bioinformatics teams to ensure data integrity and compliant pipelines, audits, and