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
What We’re Looking For:
- 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 lifecycles
- 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
Nice to Have:
- 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
Work Environment:
- 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 the Greater Seattle area
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Estimated Min Rate: $180,000
Estimated Max Rate: $230,000
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
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