Vice President – Clinical Quality Assurance

Job not on LinkedIn

🕒 July 17

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 36%

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• Serve as the organization's highest-ranking Quality leader, reporting directly to the Chief Executive Officer • Provide strategic leadership and operational oversight for SCRI's Quality Management System • Drive a culture of quality and continuous improvement across the organization • Maintain ongoing inspection readiness and advance quality initiatives supporting operational excellence and organizational growth • Provide senior Quality leadership and operational direction across SCRI • Lead, develop, and mentor the Quality Assurance team • Establish goals, performance expectations, and development plans for Quality staff • Partner with executive leadership and stakeholders on quality, compliance, and risk management • Maintain, optimize, and continuously improve the Quality Management System • Oversee policies, procedures, training, documentation practices, and quality oversight activities • Oversee audits, inspections, CAPA, deviations, investigations, and quality metrics • Use trend analysis and risk evaluation to resolve quality issues • Drive best practices, change management, and cross-functional engagement • Manage departmental priorities, budgets, and resource allocation

🎯 Requirements

• Progressive Quality Assurance, Quality Management, or compliance leadership experience in regulated healthcare, clinical research, life sciences, or similar industries • Experience managing Quality Management Systems, including audits, inspections, CAPA, deviations, change control, training, and quality metrics • Proven success leading teams, partnering across functions, and driving quality, operational improvements, and business results • Extensive knowledge of FDA guidelines, GCP, applicable regulations, Quality and Clinical IT Systems and experience • Knowledge of medical and clinical research terminology • Thorough understanding of investigative site research requirements, quality metrics, and performance measures • 7+ years' experience interpreting and applying regulatory requirements, translating them to operational practice, and providing practical guidance to leadership and cross-functional business partners • Highly effective ability to engage with senior leaders, regulators, auditors, and internal stakeholders on quality and compliance matters • Bachelor's Degree required • RAPS - Regulatory Affairs Certification highly preferred • Master's Degree preferred

🏖️ Benefits

• Comprehensive Total Rewards package supporting physical, mental, and financial well-being • Annual bonus or long-term incentive opportunities may be offered • Relocation assistance is not available • Visa sponsorship is not available