Director, Quality Systems – IVD / Companion Diagnostic
Listed on 2026-08-15
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
We are seeking an experienced Director, Quality Systems – IVD / Companion Diagnostics to join a growing clinical-stage biotechnology organization advancing oncology and precision-medicine programs. This individual will play a key role in building, leading, and continuously improving the Quality Management System supporting regulated diagnostic programs from development through validation, regulatory submission, and commercialization. This is a hands‑on leadership position for someone who understands the intersection of quality systems, diagnostic product development, design controls, and regulatory compliance.
The ideal candidate has direct experience within IVD, companion diagnostics, or regulated medical devices and is comfortable establishing scalable quality processes while partnering closely with scientific, regulatory, clinical, and external development teams.
Location: Greater Seattle Area, WA (onsite)
Type: Full Time
Compensation: Base salary $180,000–$230,000 (DOE)
Industry: Biotechnology / IVD / Companion Diagnostics
What You’ll Do:- Lead and continuously improve the Quality Management System supporting regulated diagnostic and companion diagnostic programs
- Ensure compliance with applicable requirements including 21 CFR Part 820, ISO 13485, and ISO 14971
- Provide Quality leadership across diagnostic development, validation, transfer, regulatory submission, and commercialization activities
- Establish and oversee design controls, including design inputs/outputs, verification, validation, design reviews, traceability, and design transfer
- Integrate risk‑management principles throughout the diagnostic product lifecycle
- Lead CAPA, deviations, nonconformances, investigations, change control, and document‑control activities
- Develop and maintain SOPs, quality policies, and controlled documentation
- Oversee qualification and ongoing monitoring of critical suppliers, CROs, contract laboratories, manufacturing partners, and diagnostic platform vendors
- Establish and manage quality agreements and supplier‑performance expectations
- Support internal audits, external audits, regulatory inspections, and overall inspection readiness
- Serve as a key Quality representative during FDA, ISO, partner, and regulatory interactions
- Partner closely with R&D, Regulatory Affairs, Clinical, Pathology, Operations, and external diagnostic partners
- Help build scalable Quality processes and capabilities as programs advance
- Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred
- 10+ years of Quality experience within IVD, companion diagnostics, medical devices, or another closely regulated diagnostics environment
- 5+ years of progressive Quality leadership experience
- Strong hands‑on knowledge of 21 CFR Part 820 and ISO 13485
- Working knowledge of ISO 14971 and product risk management
- Demonstrated experience with design controls and regulated product‑development life cycles
- Strong experience with CAPA, investigations, deviations, change control, and document control
- Experience with supplier quality, quality agreements, audits, and external partner oversight
- Experience supporting FDA inspections and/or ISO audits
- Ability to operate both strategically and hands‑on in a growing organization
- Strong cross‑functional communication and stakeholder‑management skills
- Direct experience with companion diagnostics (CDx)
- Experience with IHC, pathology, or biomarker‑based diagnostic programs
- Experience transitioning assays from early development into regulated commercial diagnostic products
- Experience supporting late‑stage or commercial IVD/CDx programs
- Background working with diagnostic platform providers, reagent suppliers, CROs, central laboratories, or contract manufacturers
- Experience helping establish or significantly improve a QMS within a growing organization
- Collaborative, science‑driven biotechnology environment
- High‑visibility role with significant ownership of Quality strategy and execution
- Close partnership with scientific, regulatory, clinical, and external development teams
- Hands‑on leadership position within a growing diagnostic organization
- Full‑time onsite position in…
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