Senior CLIA Quality Manager — High-Complexity Lab

Nanobiosym; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A biomedical technology company in Cambridge, MA is seeking a Quality Manager to oversee compliance and quality management in its CLIA laboratory. The ideal candidate will have a Bachelor of Science degree and a minimum of 8 years’ experience in the FDA regulated industry, particularly in medical device or in vitro diagnostics. Responsibilities include maintaining laboratory auditing standards, leading quality programs, and ensuring regulatory compliance. Strong leadership and communication skills are required for success in this role.

Qualifications

• Minimum 8 years' working in an FDA regulated industry.
• Experience in interfacing with regulatory bodies.
• Minimum 5 years' experience with GCP/GCLP regulations.

Responsibilities

• Maintain Licensure by ensuring all CLIA and state licenses are renewed.
• Lead the CLIA Quality Management Program to maintain compliance.
• Oversee laboratory audit readiness and manage audit findings.

Skills

Effective verbal and written communication skills

Attention to detail

Problem solving

Leadership ability

Education

Bachelor of Science degree in medical technology or laboratory sciences

Job description

A biomedical technology company in Cambridge, MA is seeking a Quality Manager to oversee compliance and quality management in its CLIA laboratory. The ideal candidate will have a Bachelor of Science degree and a minimum of 8 years’ experience in the FDA regulated industry, particularly in medical device or in vitro diagnostics. Responsibilities include maintaining laboratory auditing standards, leading quality programs, and ensuring regulatory compliance. Strong leadership and communication skills are required for success in this role.