McKesson · 1 day ago
Lead Clinical QA Analyst
United States
Full-time
Remote
Senior Level, Lead/Staff
$126K/yr - $210K/yr
10+ years expMcKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. The Lead Clinical QA Analyst will support the Insights & Technology organization by providing research quality expertise, ensuring compliance with regulations, and leading quality processes to enhance care delivery in oncology clinical research.
BiopharmaBiotechnologyHealth CareInformation TechnologyPharmaceutical
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
Qualification
Required
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)
Benefits
Annual bonus
Long-term incentive opportunities
Company
McKesson
McKesson distributes medical supplies, information technology, and care management products and services.
10001+ employees
H1B Sponsorship
McKesson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (149)
2024 (129)
2023 (82)
2022 (142)
2021 (144)
2020 (154)
Funding
Current Stage
Public CompanyTotal Funding
unknown1994-11-18IPO
Leadership Team
Brian Tyler
CEO
Jim McAuliffe
CFO
Recent News
2026-01-06
2026-01-03
Seattle TechFlash
2025-12-22
Company data provided by crunchbase