Senior Quality Specialist

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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 Quality Specialist, Sr. is responsible for assisting Quality Leadership with ensuring compliance, optimizing quality processes, and implanting strategic enhancements of the Quality Management System (QMS) in support of clinical trial operational activities. The Quality Specialist, Sr. will serve as administrator for the quality management software (QMS) and is responsible for development, configuration, and management of the QMS.

Please note:

this is a hybrid role and requires 2‑3 days per week of onsite presence at our office in Johnson City, TN.

• Leads and project manages QMS activities, ensuring robust implementation and continuous improvement of document control, change control, non‑conformance reporting, and supplier qualification/requalification processes within the QMS framework.
• Serves as team lead, in a non‑supervisory capacity, on QMS‑related systems, ensuring compliance with regulatory standards.
• Responsible for QMS metrics and reporting to leaders across the company.
• Supervise and assist in management of QMS Quality Event reporting and related investigation, root cause analysis, proposed corrective and/or preventive measures, and timely closure.
• Trains QMS users on workflow and associated tasks for modules within the QMS.
• Leads configuration, optimization, and continuous improvement initiatives for electronic QMS (eQMS), ensuring alignment with organizational quality objectives and regulatory requirements.
• Identifies and drives QMS‑centric Lean and process efficiency initiatives, leveraging data analytics and stakeholder input to enhance system performance and user experience.
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses.
• Provide expert‑level QMS compliance guidance and strategic quality assurance consultation to internal teams and external partners, ensuring adherence to industry best practices and regulatory expectations.
• Schedules and conducts monthly quality review meetings as required.
• Prepare training materials and conduct training for QMS topics.
• Collaborates with Human Resources regarding training program requirements affected by the QMS.
• Serves as Quality subject matter expert for configurable systems validation projects.
• Conducts research and compiles reports.
• Performs other tasks as defined by the Quality Assurance Leadership.

• 2‑year Associate degree with 8‑10 years related experience and/or training required, or
• 4‑year bachelor’s degree preferred with 5‑7 years of Quality Assurance Experience.

• Must possess strong organizational and interpersonal skills.
• Experience with QMS platforms such as Veeva is highly preferred.
• Proven track record of leading QMS implementations or enhancements is a strong asset.

None

• 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.

Minimal

• 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…