Site Quality Lead - Cleveland, OH

LabConnect•Cleveland, OH

2d•Onsite

About The Position

The Site Quality Lead is responsible for ensuring the quality and regulatory compliance of operations within a central laboratory supporting clinical trials. This role oversees the implementation and maintenance of the Quality Management System (QMS), ensures adherence to GCP and applicable regulatory standards, and facilitates the site audit program. The manager plays a key role in driving continuous improvement and maintaining high standards of data integrity and clinical quality performance. Please note: this role will be performed onsite at our Cleveland, OH office.

Requirements

Bachelor’s degree in life sciences, medical technology, or related field.
Minimum 4 years of experience in a central lab or clinical trial lab environment, with at least 2 years in a quality management role.
Strong understanding of the CFR’s, CLIA, CAP checklists, GCP, and ICH guidelines as they pertain to clinical trial operations.
Strong understanding of the clinical laboratory and clinical trials environments.
Excellent communication, leadership, and analytical skills.

Responsibilities

Champion site-wide Quality initiatives, ensuring alignment with global regulatory standards and corporate excellence (e.g., CLIA, CAP, GCP, ICH, FDA, EMA).
Assess and report on compliance with clinical trial protocols, sponsor requirements, and regulatory guidelines.
Prepare for and facilitate sponsor audits, regulatory inspections (e.g., CLIA, CAP, FDA, EMA), and internal audits.
Coordinate timely and strategic resolution of audit findings and CAPAs, reinforcing a culture of accountability and continuous improvement.
Manage and oversee Quality Events including investigation, root cause analysis, implementation of robust CAPA plans, and effectiveness checks.
Collaborate with lab operations, data management, project teams, and others to ensure quality in sample handling, testing, and reporting.
Review  method validations, equipment qualifications, and laboratory investigations.
Identify process inefficiencies and facilitate quality improvement initiatives across departments.
Monitor and report quality KPIs (e.g., audit outcomes, deviation trends, CAPA effectiveness).
Provide regular updates to leadership and contribute to strategic quality planning.
Prepare training materials and conduct training for QMS topics.
Collaborates with Human Resources regarding training program requirements affected by the QMS.
Performs other tasks as defined by Quality Assurance Leadership