Lead Quality Auditor

Overview

Lab Connect 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.

The Lead Quality Auditor executes internal and external audits, supports vendor and client audits, and drives post-audit actions to completion. This role strengthens audit readiness across the organization and supports the Director in maintaining global regulatory compliance.

Hybrid position requiring candidates to be within commuting distance to Johnson City, TN or Cleveland, OH for onsite work 2–3 days a week.

• Define the scope, communicate plans, and implement effective audits that are risk-based.
• Lead or serve as host for Client Audits, Vendor Audits, Internal Audits, Gap Analyses, Trial Specific Audits and other key auditing, risk mitigation, and regulatory assessment activities.
• Assisting leadership in assuring organizational readiness for audits and inspections.
• Provide audit-related insights, data, and trend reporting to support leadership decision making and escalation of compliance risks.
• Assist in management of Non‑Conformance reporting and their related corrective and preventive measures.
• Apply risk‑based thinking in evaluating evidence, determining audit observations, and prioritizing follow‑up actions.
• Support inspection preparedness activities, including document retrieval, evidence coordination, and facilitating communication between internal stakeholders and inspectors.
• Execute the approved audit plan, ensuring timely planning, scheduling, and completion of assigned audits in alignment with risk and business priorities.
• Maintain and expand regulatory knowledge to the ICH Principles of GCP, General Data Privacy Regulations and Computer Systems Validation requirements, GLPs, CLIA, the CAP checklists, ISO 15189, and other applicable regulations/standards.
• Review, write, and edit Internal and External Audit reports and responses.
• Drive the closure of audit actions by collaborating with process owners, ensuring quality, completeness, and timely entry into the eQMS.
• Support vendor qualification, ongoing monitoring, and audit activities in alignment with vendor governance processes.
• Coach and support team members in audit and compliance practices to strengthen overall organizational capability.
• Working collaboratively across all functions including internal and external partners.
• Perform other related duties and tasks as necessary or as assigned.

• Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Medical Technology, or Physical Science).
• Minimum of 6–8 years of experience in Quality within the clinical laboratory, central laboratory, biotech, or pharma industry with expertise in GxPs and ensuring regulatory compliance including interaction with Health Authorities. Must have minimally 4 years of auditing and inspections experience.
• Strong knowledge of regulatory requirements (e.g., CLIA, CAP, ISO 15189, GxP, CFR Part 11, Annex 11, ISO
  9001, ICH guidelines) and industry standards.
• Very strong communication and collaboration skills, with timely decision making and risk management.
• Master’s degree preferred.

• Excellent problem‑solving skills and the ability to drive continuous improvement initiatives.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross‑functional meetings and influence without authority.
• Ability to lead audit interviews, challenge stakeholders constructively, and maintain professionalism in…