Clinical Laboratory QA & Regulatory Specialist (Individual Contributor)

Job Summary

 

We are looking for a unique "unicorn" candidate—a Clinical Laboratory QA & Regulatory Specialist who thrives at the intersection of hands-on execution and high-level strategy. This is a full-time, in-house individual contributor role based directly in our Fremont, California laboratory. Instead of simply maintaining an existing corporate compliance program, you will actively architect, write, and scale the quality and regulatory frameworks for novel NGS-based Laboratory Developed Tests (LDTs). If you are tired of being a small cog in a massive reference testing facility and want the broad ownership of building a clinical lab's compliance infrastructure from the ground up, this role is for you.

 

Key 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.

 

Qualifications & Skills

• Education: Bachelor’s or Master’s degree in Molecular Biology, Genetics, Bioinformatics, or a closely related life science discipline.
• Experience: 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.
• Technical Domain Expertise: 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).
• LDT Regulatory Acumen: 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.
• Startup Mentality: 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.
• Communication: Exceptional interpersonal and technical writing skills; able to translate highly complex legal and regulatory mandates into actionable items for scientists and engineers.