Lead Clinical QA Analyst

McKesson•Irving, TX

About The Position

This position supports the Insights & Technology organization, providing research quality expertise for SCRI and Genospace. Genospace builds data and technology solutions that enable oncology clinical research, precision medicine, and real-world data applications. Our platform powers capabilities such as EHR-to-EDC data transfer, clinical trial matching, and analytics that connect sites, sponsors, and research networks—accelerating clinical trial execution and improving access to innovative therapies. As a Senior Research Quality Assurance Specialist, you will ensure compliance with SOPs, FDA guidelines, ICH-GCP standards, and applicable regulatory requirements. You’ll lead quality processes, monitor key metrics, manage investigations, and support audit and inspection readiness—all while fostering a culture of continuous improvement, patient safety, and data integrity.

Requirements

Bachelor’s degree in Science, Engineering, Life Sciences, Clinical Research, Quality Assurance, or related field; advanced degree preferred.
Deep knowledge of FDA guidelines, ICH-GCP principles, and applicable regulatory requirements.
Expertise in risk-based approaches to software validation and compliance frameworks.
Proven leadership in quality processes (Change Control, CAPA, etc.) and risk-based methodologies.
Technical proficiency in clinical trial management systems, electronic data capture, and Microsoft Office.
Exceptional communication, organizational, and problem-solving skills.
Strong collaboration and relationship-building abilities.
Extensive experience in clinical research QA and regulatory compliance ( 10+ years ).
Hands-on expertise with clinical software QA ( 5+ years ).
Strong regulatory knowledge (FDA, ICH-GCP) and experience interacting with regulators.
Leadership in quality processes and risk-based approaches.
Technical proficiency in clinical systems and data tools (e.g., Quality Validation).

Responsibilities

Lead and support Research Quality activities to ensure adherence to policies, ICH-GCP, FDA guidelines, and applicable regulations.
Develop and maintain policies, procedures, and controlled documents for Research Quality and supporting business units.
Implement risk-based quality structures and tools to monitor compliance and performance.
Deliver training on quality assurance initiatives, regulatory compliance, and industry best practices.
Manage robust document and change control programs.
Collect, analyze, and report quality-related metrics, including audit findings and compliance indicators.
Utilize QA tools to assess Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs).
Conduct reviews of performance metrics to identify improvement opportunities and drive corrective actions.
Prepare documentation for internal and external reporting as required.
Serve as subject matter expert and escalation point for investigations and quality-related issues.
Oversee root cause analysis and ensure corrective and preventive actions are implemented and tracked.
Ensure accuracy and completeness of QA outputs prior to submission or reporting.
Assist with preparation for external audits, inspections, and quality oversight activities.
Support communication with sponsors and regulatory agencies.
Contribute to inspection readiness and maintain compliance documentation.