Site Quality Manager - Cleveland, OH/Hybrid

Essential Duties And 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.
• Carefully 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.

Education and Experience

• 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.

Skills and Abilities

• 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.

Physical Demands

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.
• Sit 75% of the week.
• Stand 25% of the week.
• Walk and/or reach with hands and arms 15% of the week.
• Read text of various sizes.
• Communicate with others and hear.
• Lift, pull and/or push up to 25 pounds.

Travel Requirements

• Minimal