Site Quality Lead

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

Job Summary

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 position will be performed from our Cleveland, Ohio office.

Essential Duties and Responsibilities

• Lead and 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.
• Lead preparation and facilitation of 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 senior 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

Education and Experience

• Bachelor’s degree in life sciences, medical technology, or related field.
• 5 years experience in Quality role
• Minimum 5 years of experience in a clinical lab QA experience or clinical trial lab environment
• 2 years in a quality leadership role

Skills and Ability

• 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

Join our team and discover how your work can impact patients' lives around the world!

Some of the Perks our LabConnectors Love:

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!

In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call 1 (423) 722-3155.