Part-Time CLIA Lab Director - Dual-Lab Oversight

Stryker Corporation; Burlington (MA); Hybrid; Confidential; Part time

Benefits offered by this job

Travel to Heidelberg twice yearly

Travel to Burlington, MA twice yearly

Job summary

ProtaGene invites a part-time Laboratory Director to oversee two CLIA laboratories in Burlington, MA, and Heidelberg, Germany. The role ensures adherence to CLIA, CAP, and state requirements through method reviews, validation, and staff competency oversight.

The ideal candidate will possess MD/DO or doctoral qualifications with relevant board certification and substantial experience directing high-complexity testing, supporting inspections and compliance needs.

Qualifications

• Eligible to serve as Clinical Laboratory Director for two CLIA laboratories performing high-complexity testing, per 42 CFR §493.1443 and MA/PA/CA requirements.
• MD/DO license in Massachusetts with board certification in pathology, or doctoral degree with HHS-approved specialty board.
• For non-physician candidates, at least two years of lab training/experience and two years directing high-complexity testing.

Responsibilities

• Act as Part-time/Consultant Laboratory Director for two CLIA labs in Burlington, MA and Heidelberg, Germany.
• Ensure compliance with CLIA, CAP, and state requirements including MA, CA, PA; NY qualification asset.
• Review and approve test methods, validation, procedures, and reporting formats.
• Oversee laboratory personnel training, competency, and delegated responsibilities.
• Conduct minimum two on-site oversight visits per calendar year to each lab location; travel costs covered separately.
• Review quality-control and proficiency testing data and take corrective actions as needed.
• Provide scientific and clinical consultation on complex technical, quality, or compliance matters.
• Support regulatory inspections and license applications; assist customer audits.
• Participate in oversight meetings/site visits and respond to significant quality or patient impact events.
• Maintain documentation of oversight, reviews, decisions, and delegated responsibilities.
• Contribute to corporate safety, environmental and quality standards.

Skills

Clinical Laboratory Director eligibl

Molecular diagnostics experience

Regulatory compliance knowledge

Leadership and oversight

Education

MD/DO licensed in MA or equivalent

Doctorate in chemical/biological/medical lab science

2+ years directing high-complexity testing

Job description

ProtaGene invites a part-time Laboratory Director to oversee two CLIA laboratories in Burlington, MA, and Heidelberg, Germany. The role ensures adherence to CLIA, CAP, and state requirements through method reviews, validation, and staff competency oversight.

The ideal candidate will possess MD/DO or doctoral qualifications with relevant board certification and substantial experience directing high-complexity testing, supporting inspections and compliance needs.