Part-Time CLIA Lab Director - Genomics & Compliance

Stryker Corporation; Burlington, Northern (MA, KY); Hybrid; Confidential; Part time

Benefits offered by this job

Part-time consulting role

On-site visits to Burlington and Heil­

Competitive rate: $500/hr

Job summary

ProtaGene seeks a part-time Consulting Laboratory Director to oversee two CLIA high-complexity laboratories in Burlington, MA and Heidelberg, Germany, ensuring compliance with CLIA, CAP, and state regulations.

The role requires MD/DO or doctoral degree with board certification or equivalent, plus experience directing high-complexity testing, QA, validation, and regulatory inspections, with at least two on-site visits annually.

This position offers a 12-hour/month commitment at $500/hour.

Qualifications

• Eligible to serve as CLIA Laboratory Director for two high-complexity laboratories.
• Meet Massachusetts CLIA director-qualification pathways (MD/DO or doctoral degree with board certification).
• Experience directing or supervising high-complexity testing in relevant specialty.

Responsibilities

• Oversee two CLIA laboratories for compliance with CLIA, CAP and state requirements.
• Review and approve test methods, validation activities, procedures, report formats, and major changes.
• Ensure personnel competency, training, and delegated responsibilities; maintain documentation of oversight and decisions.

Skills

Laboratory leadership

Regulatory knowledge

Quality management

Team collaboration

Problem solving

Education

MD or DO or PhD in relevant field

Job description

ProtaGene seeks a part-time Consulting Laboratory Director to oversee two CLIA high-complexity laboratories in Burlington, MA and Heidelberg, Germany, ensuring compliance with CLIA, CAP, and state regulations.

The role requires MD/DO or doctoral degree with board certification or equivalent, plus experience directing high-complexity testing, QA, validation, and regulatory inspections, with at least two on-site visits annually.

This position offers a 12-hour/month commitment at $500/hour.