Quality Operations Leader, Central Lab & Compliance

LabConnect; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Financial Security (Base Pay, 401k)

Health Benefits

PTO + Holidays

Disability & Life Insurance

Career growth opportunities

Job summary

LabConnect is seeking a Quality Assurance professional to champion quality initiatives, oversee CAPA processes, and coordinate audits across central lab operations. The role emphasizes regulatory compliance with CLIA, CAP, GCP, ICH, FDA, and EMA guidelines, while leading cross-functional teams to ensure data integrity and consistent quality across studies.

Ideal candidates will have 4+ years in lab quality roles, a life sciences degree, and familiarity with eQMS (Veeva) and document control.

Qualifications

• Bachelor's degree in life sciences, medical technology, or related field.
• Minimum 4 years of experience in a central lab or clinical trial lab, with at least 2 years in a quality management role.
• Professional quality certifications are optional.

Responsibilities

• Champion Quality initiatives aligned with global regulatory standards (CLIA, CAP, GCP, ICH, FDA, EMA).
• Assess and report on compliance with clinical trial protocols and regulatory guidelines.
• Manage and oversee Quality Events from issue identification through CAPA and effectiveness monitoring.
• Collaborate with lab operations, data management, and project teams to ensure quality in sample handling, testing, and reporting.
• Prepare for and facilitate sponsor audits and regulatory inspections.

Skills

CFRs & Guidelines

CLIA knowledge

GCP knowledge

CAP checklists

ICH guidelines

Quality management

Analytical skills

Communication

Leadership

Regulatory affairs

Education

Bachelor's degree in life sciences

Tools

eQMS (Veeva)

eLMS

Document control

MS Office

MS Project

Job description

LabConnect is seeking a Quality Assurance professional to champion quality initiatives, oversee CAPA processes, and coordinate audits across central lab operations. The role emphasizes regulatory compliance with CLIA, CAP, GCP, ICH, FDA, and EMA guidelines, while leading cross-functional teams to ensure data integrity and consistent quality across studies.

Ideal candidates will have 4+ years in lab quality roles, a life sciences degree, and familiarity with eQMS (Veeva) and document control.