Research Quality Manager

Job not on LinkedIn

🔥 1 minute ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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

• Implement the quality assurance program • Manage and perform consult/support visits at investigative sites • Assist with onsite external audits and inspections • Provide routine quality support for assigned investigative sites • Develop and maintain relationships with investigative sites and SCRI departments and colleagues • Monitor and modify policies and procedures • Utilize quality tools to assess study-operation quality indicators • Monitor and prioritize quality indicators for all sites using a risk-based approach and Quality by Design framework • Identify and report quality deficiencies to directors and appropriate colleagues • Assist in developing and modifying process documents • Assist with preparing and hosting external audits • Assist research staff in maintaining regulatory compliance • Perform process/focused audits of research sites and report findings to leadership • Ensure timely and appropriate follow-up on deficiencies • Communicate observations and deficiencies to Site Directors/Managers and study PIs • Assist sites with root-cause analysis and responses to external audits and CAPAs • Maintain audit records and reports • Communicate with clinical-trial monitors and auditors as needed • Educate staff on quality-improvement methods and industry trends • Perform other duties as assigned

🎯 Requirements

• Bachelor’s Degree required • Minimum 3 years’ work experience in Quality Assurance, Quality Management, or Quality Auditing, preferably in a clinical research, healthcare or life sciences field • Expertise in GCP, FDA, and other applicable regulations in a risk-based environment • Master’s Degree preferred

🏖️ Benefits

• Comprehensive benefits 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