Job Details

About the Role

Our client, a diagnostics company, is seeking a Quality Assurance Manager to be responsible for establishing, implementing, and maintaining the Quality Management System for a high-complexity molecular diagnostics laboratory. This role will play acritical part in ensuring compliance with CLIA, CAP, and NYSDOH requirements while supporting efficient laboratory operations.

This position requires a quality professional who can operate effectively in a growing organization, building foundational quality systems from the ground up while partnering closely with Laboratory Operations. The Quality Assurance Manager will ensure that quality processes are compliant, practical, and designed to evolve as the laboratory expands, enabling inspection readiness without unnecessary complexity.

This role reports to the Director of Quality and works in close partnership to share responsibility for quality systems. This individual has the opportunity to implement and execute robust quality systems, working in tandem with the Director of Quality to support design control and test validation responsibilities.

Key Responsibilities

• Establish and maintain a right-sized QMS aligned with CLIA, CAP, and NYSDOH requirements.
• Build and own core quality processes, including document control, change management, deviations, CAPA, training and competency oversight, internal audits, management review, supplier quality, and reagent quality oversight.
• Lead the prioritization, creation, implementation, and training of SOPs in a phased, risk-based manner that is aligned with laboratory readiness and business milestones.
• Lead or support inspection readiness and regulatory audits, including preparation, execution, and follow-up.
• Partner closely with Laboratory Operations, Tech Transfer, Automation, IT, and R&D to integrate quality into daily workflows and ensure systems are usable and effective.
• Lead investigations and corrective actions using risk-based root cause analysis.
• Define, track, and trend quality metrics to identify systemic risks and drive continuous improvement.
• Operate effectively in a lean QA environment, sharing quality system ownership and execution with the Director of Quality.
• Support the hiring, and development, and mentorship of additional QA personnel as operational needs grow.
• Manage external consultants or contractors as needed.
• Ensure personnel qualifications, scopes of responsibility, and quality records are complete, accurate, and maintained in accordance with regulatory requirements.

Qualifications

Required

• Bachelor's degree in a scientific, technical, or related field.
• 5+ years of Quality Assurance experience in a regulated clinical laboratory or diagnostics environment.
• Experience supporting high-complexity molecular testing and Laboratory Developed Tests.
• Experience leading or supporting CLIA, CAP, and/or NYSDOH audit inspections.[LB1]
• Strong working knowledge of CLIA, CAP, and NYSDOH requirements.
• Experience building, implementing, or significantly improving quality systems.
• Possesses strong communication skills with a dDemonstrated ability to work cross-functionally in a highly collaborative, fast-paced environment, .

Preferred

• Experience leading or supporting CLIA, CAP, and/or NYSDOH inspections.
• Startup or early-stage laboratory experience.
• Experience acting as a primary or sole QA resource.

How We Work

• Quality is a shared responsibility, not a siloed function.
• We build fit-for-purpose systems that meet regulatory requirements and support day-to-day operations.
• Priorities are clearly defined and revisited as the organization grows.
• The Quality team operates lean by design, with intentional planning for scale.
• We value transparency, collaboration, and sustainable execution over unnecessary complexity.

What Success Looks Like

• The laboratory maintains continuous inspection readiness.
• Quality systems are effective, understood, and consistently used across the organization.
• Regulatory requirements are met without creating unnecessary operational burden.
• The quality function adapts smoothly as laboratory operations grow.