Chief Lab Operations Regulatory & Quality Leader

Colaborate; San Diego (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Colaborate is seeking a Head of Laboratory Operations, Regulatory & Quality to establish and maintain CLIA-compliant systems for a Commercial Test Laboratory in the United States. Lead regulatory programs, quality systems, audits, and capacity planning to ensure reliable patient testing.

The role requires BS degree, senior operations/regulatory leadership, and proven ability to manage regulatory submissions, vendor relations, and cross-functional collaboration in a fast-paced startup environment.

Qualifications

• Senior management level experience in operations and regulatory for IVD/manufacturing or pharmaceutical operations; CLIA lab experience preferred.
• Strong analytical and problem-solving skills; organized and efficient.
• Proven interpersonal, communication and presentation skills; excellent time management.

Responsibilities

• Establish core systems including facilities, utilities, services, staffing and operations for commercial test laboratories.
• Support planning and execution of U.S. product commercialization.
• Submit applications and maintain compliance with regulations and regulatory agencies.
• Manage resources to maintain CLIA lab registration, accreditations and state regulations.

Skills

Regulatory leadership

Analytical skills

Project management

Communication

Attention to detail

Education

Bachelor of Science degree

Tools

Excel

Word

PowerPoint

Job description

Colaborate is seeking a Head of Laboratory Operations, Regulatory & Quality to establish and maintain CLIA-compliant systems for a Commercial Test Laboratory in the United States. Lead regulatory programs, quality systems, audits, and capacity planning to ensure reliable patient testing.

The role requires BS degree, senior operations/regulatory leadership, and proven ability to manage regulatory submissions, vendor relations, and cross-functional collaboration in a fast-paced startup environment.