Job Description
About MyOme
MyOme's mission is to provide clinically actionable genetic information to patients throughout their lives. We combine clinical-grade whole genome sequencing, advanced methods for genome interpretation, and seamless digital tools for doctors and patients to order and access results. Our team is composed of seasoned entrepreneurs, scientists, and operators, and we're backed by top-tier investors.
Job Description
We're looking for a seasoned Lab QA Manager with deep experience in regulated environments to take ownership of quality, safety, and EH&S (Environment, Health & Safety) systems in our lab. You will manage inspection readiness, lead core QA functions, and free up the Compliance leadership to focus on strategic priorities such as FDA submissions, consortium trial oversight, and vendor program scaling.
Responsibilities
- Maintain and expand the quality management system (QMS) including CAP, CLIA and internal SOPs, change control, and internal audits.
- Lead regulatory inspection readiness and responses (CLIA/CAP inspections, FDA audit readiness).
- Own CAPA investigations, root cause analysis, and follow-through.
- Manage EH&S compliance: safety audits, lab hazard assessments, waste/disposal protocols, emergency preparedness.
- Oversee lab readiness evaluation, equipment qualification, and documentation.
- Scale vendor qualification processes: auditing suppliers, reviewing documents, and maintaining vendor performance tracking.
- Support data privacy/security compliance: HIPAA operations, USDP implementation, and foundational security measures preparing for potential SOC 2 attestation.
- Serve as primary QA liaison during escalation: supporting audit responses, external review boards, or internal quality issues.
- Develop a culture of continuous quality improvement, training, and awareness across lab teams.
Skills and Experience
- 5+ years in clinical diagnostics or biotech QA, ideally in CLIA/CAP-regulated labs.
- Required experience in managing QA processes in a CLIA, CAP and NYS-CLEP approved clinical laboratory.
- Direct experience leading through at least one full regulatory inspection (e.g., CAP, CLIA, FDA).
- Proven ability owning CAPA systems and corrective/preventive action lifecycles.
- Hands-on EH&S program management in laboratory or biotech settings.
- Experience with HIPAA compliance and security/privacy governance; familiarity with SOC 2 preferred.
- Strong communicator, adept at cross-functional collaboration with lab operations, engineering, clinical teams, and vendors.
- Comfortable in a fast-paced, dynamic startup environment-structured but flexible, scrappy yet documentation-driven.
- Detail-oriented and systems-minded, with a proactive mindset.
Location, Compensation, and Benefits
- Location: Hybrid - primarily onsite at the laboratory (minimum 3 days/week), with flexibility for occasional remote work as needed.
- Compensation: $120-140K/year depending on experience; equity; and the following benefits:
- Company-paid health/vision/dental benefits
- 401K
- Unlimited PTO
- Company-sponsored offsites and team meals during in-person meetings
- Direct access to company leadership and opportunity to grow into an operational leadership role
Why Work at MyOme?
Join us if you:
- Want to make an impact at the intersection of healthcare and technology, changing the way people engage with their health at the genetic level
- Enjoy rolling up your sleeves, taking initiative, and being empowered to lead
- Value humility, transparency, and collaborative problem-solving
- Thrive in fast-moving, dynamic environments with smart, driven teammates
- Appreciate competitive compensation, meaningful equity, and excellent benefits
Learn More: myome.com
Job Tags
Casual work, Flexible hours, 3 days per week,