Senior Director, Quality – Investigations, CAPA, Recall

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🔥 6 minutes ago

🏛️ District of Columbia – Remote

🏛️ District of Columbia – Remote

💵 $181.1k - $301.9k / year

⏰ Full Time

🟠 Senior

👔 Director

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

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

• Provides strategic leadership and direction for Investigation, CAPA, Recall, Complaint, Quarantine, and related quality programs across Supply Chain Operations. • Leads second-level and first-level managers and is accountable for the performance, services, and outcomes of the Quality Investigations, CAPA, and Recall teams. • Develops and implements operational processes, procedures, goals, metrics, and budget expectations for the Investigation, CAPA, and Recall programs. • Regularly engages with senior leadership and cross-functional stakeholders on matters impacting multiple functional areas and business units. • Serves as the lead for Quality Investigations and CAPA across Supply Chain Operations, including distribution centers and Central Fill Pharmacy locations. • Establishes and monitor key performance indicators (KPIs) for investigations, CAPA, and recall processes, reporting on trends, effectiveness, and compliance to senior management. • Drives continuous improvement of the Quality Management System, with a focus on strengthening Investigation, CAPA, and Recall programs to address quality issues quickly and effectively.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Engineering, or other technical/equivalent field experience required, advanced degree preferred. • Minimum of 13 years of progressive experience in professional quality assurance roles in pharmaceutical manufacturing, pharmaceutical distribution, healthcare, or another highly regulated environment, including at least 6 years of direct people management experience. • Extensive knowledge of and practical experience with drug product regulations and detailed knowledge of FDA, DEA, State Board of Pharmacy, and other applicable regulatory requirements. • Deep understanding of end-to-end supply chain operations across pharmaceutical manufacturing, distribution centers, third-party logistics providers, and pharmacies. • Strong expertise in Investigation, CAPA, and Recall programs, including relevant industry standards and the ability to develop strategy and drive the development, implementation, and enforcement of processes and procedures to assure quality. • Proven track record of successfully managing complex quality investigations, implementing effective CAPA, and executing product recalls. • Strong digital literacy, including effective use of electronic quality management systems, analytics, dashboards, and digital tools to support insight, decision-making, and continuous improvement. • Experience in managing and developing high-performing teams.

🏖️ Benefits

• Competitive compensation package • Annual bonus or long-term incentive opportunities