Quality Assurance Team Lead

Alliance For MultiSpecialty Research LLC•Knoxville, TN

About The Position

The QA Team Lead is a senior-level quality role responsible for leading audit, inspection, and CAPA activities across all clinical research sites while directly supporting the development and execution of the organization’s quality strategy. Reporting to the Director of Quality Assurance, this role combines people leadership with deep technical expertise, serving as both a manager of QA staff and a hands-on subject matter expert in regulatory compliance and quality systems. The QA Team Lead provides day-to-day leadership, direction, and coaching to Quality Assurance Specialists while actively contributing to complex audits, regulatory inspections, and CAPA strategy. This role ensures consistent, organization-wide quality oversight, inspection readiness, and implementation of risk-based, data-driven quality improvements. As a key quality authority, the QA Team Lead serves as a primary escalation point for high-risk or sensitive quality issues and plays a lead role during regulatory inspections, sponsor and CRO audits, and critical internal audits. The role partners closely with the Director of Quality Assurance to support regulatory interactions, drive compliance strategy, and strengthen the Quality Management System (QMS). This position maintains accountability for the end-to-end audit and inspection lifecycle, including response development, CAPA governance, and effectiveness verification, ensuring outputs are scientifically sound, regulatorily aligned, and focused on sustainable systemic improvement. The QA Team Lead serves as a central quality partner supporting audit, inspection, and CAPA activities across all clinical research sites. This role provides organization‑wide quality oversight with a focus on inspection readiness, regulatory compliance, and meaningful quality improvement through data‑driven and risk‑based practices. As a senior subject matter expert, the position plays a lead role during regulatory inspections, sponsor and CRO audits, and complex internal audits, acting as a primary quality point of contact during escalated or high‑risk situations. The role supports the full audit and inspection response lifecycle, helping ensure responses are scientifically robust, aligned with regulatory expectations, and positioned to address both immediate observations and broader systemic risks. A significant aspect of the role is CAPA strategy and quality improvement. The QA Team Lead partners with sites and functional teams to design, assess, and refine CAPA approaches, offering expertise in root cause analysis, risk evaluation, and effectiveness measures. By integrating audit outcomes, deviation trends, and monitoring insights, the role helps identify cross‑site quality risks and contributes recommendations to strengthen the Quality Management System (QMS). The role emphasizes proactive quality engagement by applying quality‑by‑design principles through risk‑based review of protocols, study plans, and essential documents. Working closely with operational teams, the position provides practical input on preventive strategies before study initiation and throughout study conduct. As a trusted advisor, the role offers guidance on complex regulatory interpretations, protocol challenges, and compliance decisions, supporting sites through uncertainty and high‑pressure scenarios. In collaboration with site leadership, Director of QA, and cross‑functional partners, the QA Team Lead contributes to SOP lifecycle activities, process alignment, and continuous improvement efforts. The role also participates in assessments of informed consent processes and study conduct to support participant protection and regulatory alignment. As a mentor and quality resource, the position supports the development of site personnel through coaching, advanced training, and facilitation of quality discussions. By modeling accountability, partnership, and regulatory rigor, the role helps strengthen organizational quality maturity and foster a sustainable culture of compliance. To consistently embody AMR Clinical’s Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Quality Assurance Team Lead reports directly to the Director of Quality Assurance. Classification: Exempt

Requirements

Extensive experience in clinical research, healthcare compliance, or quality assurance, with demonstrated progression toward increased responsibility and leadership.
Advanced ability to exercise strategic judgment and independent decision‑making, especially in high‑risk or ambiguous situations.
Demonstrated leadership abilities, including mentoring junior staff, influencing stakeholders, and driving cross‑functional collaboration.
Exceptional attention to detail combined with the ability to identify systemic trends, risk patterns, and process improvement opportunities.
Outstanding verbal and written communication skills, including the ability to interact confidently with executive leadership, investigators, auditors, and regulatory bodies.
Expert-level task prioritization and project management skills, with the ability to manage complex workflows and competing deadlines across multiple sites.
Advanced proficiency with office productivity tools, quality management systems, and audit‑tracking software.
Strong follow‑through and accountability, ensuring timely closure of quality issues and audit findings.
Highly collaborative and solutions-oriented, with a demonstrated ability to build strong working relationships across clinical, operational, and leadership teams.

Responsibilities

Provide direct oversight of QA Specialists, including workload management, coaching, and performance feedback.
Support hiring, onboarding, and training of QA staff in collaboration with QA leadership and Human Resources.
Mentor team members in audit execution, CAPA development, and regulatory interpretation.
Foster a culture of accountability, collaboration, and continuous improvement.
Lead and participate in high-impact regulatory inspections, sponsor audits, and CRO audits.
Oversee inspection readiness activities across sites, including preparation strategies and staff coaching.
Review audit reports and inspection responses, ensuring accuracy, quality, and compliance.
Serve as a primary QA contact during escalated or complex audit and inspection scenarios.
Lead the development, review, and approval of CAPA plans, ensuring robust root cause analysis and risk assessment.
Guide teams in applying advanced quality tools (e.g., 5 Whys, risk impact assessments).
Oversee CAPA effectiveness checks to ensure sustainable resolution of issues.
Analyze audit findings, deviations, and quality metrics to identify systemic risks and drive cross-site improvements.
Plan and prioritize internal audits based on risk, trends, and organizational needs.
Conduct and oversee complex or high-risk internal audits.
Synthesize audit data into actionable insights and present trends to leadership.
Drive risk-based quality initiatives, including proactive review of protocols, study plans, and essential documents.
Provide expert guidance on regulatory interpretation, protocol compliance, and operational decision-making.
Review monitoring reports, deviations, and quality metrics to identify trends and escalate risks.
Ensure adherence to GCP, SOPs, and applicable regulatory requirements.
Support sites in maintaining continuous inspection readiness.
Act as a key escalation point for compliance issues and regulatory inquiries.
Contribute to SOP lifecycle activities, including development, review, and revision.
Identify process gaps and lead initiatives to improve and harmonize quality systems.
Participate in quality governance meetings and provide data-driven recommendations.
Lead risk-based review of protocols and study documents to identify potential issues early.
Partner with operational teams to implement preventive quality strategies throughout the study lifecycle.
Collaborate with site leadership, clinical operations, and other stakeholders to address quality risks.
Contribute to strategic quality initiatives and organizational projects.
Provide expert input to strengthen compliance culture and operational excellence.