Senior Manager, Quality Investigation – CAPA

Job not on LinkedIn

🔥 5 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $140k - $145k / year

⏰ Full Time

🟠 Senior

👔 Manager

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This company has sponsored H1B visas in the past.

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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

• Lead and develop the Investigation/CAPA team • Set priorities, assign work, monitor workload and performance, and provide coaching and feedback • Ensure investigations, CAPAs, regulatory notifications, trend reports, and self-audits are completed on time and meet quality requirements • Update Investigation/CAPA procedures, work instructions, training, and tools • Oversee complex product quality investigations, temperature excursions, complaints, quarantines, critical events, and suspect or illegitimate product cases • Guide investigation strategy, root cause analysis, risk assessment, escalation, product disposition support, and final conclusions • Implement improvements to quality systems and processes, including electronic quality management system updates and standardized tools • Work with USPD teams and locations to implement process changes • Track investigation and CAPA performance, including aging, timeliness, effectiveness, and recurring trends • Share findings with leadership and adjust priorities or initiate corrective action • Ensure compliance with FDA, DEA, Drug Supply Chain Security Act, Good Distribution Practice, current Good Manufacturing Practice, data integrity, and internal quality requirements • Partner with Enterprise Quality, Operations, distribution centers, Transportation, Recall, Global Security, and other groups to resolve issues • Represent Quality on audits, inspections, projects, and cross-functional initiatives • Present technical information, coordinate assigned work, and follow through on commitments • Manage the team’s approved operating expenses, including applicable electronic quality management system costs

🎯 Requirements

• Degree or equivalent experience • Typically 9+ years of professional experience • 1+ years of supervisory and/or management experience • Bachelor’s degree in Engineering, Life Sciences, or a related field • At least 9 years of progressive experience in pharmaceutical quality, investigations, CAPA, regulated distribution, cold-chain operations, quality systems, or another highly regulated environment • At least 1 year of direct people-management or supervisory experience • Experience leading complex investigations and CAPAs, assessing risk, resolving quality or compliance issues, and driving timely, effective outcomes • Working knowledge of FDA requirements, including 21 CFR and the Drug Supply Chain Security Act • Knowledge of DEA requirements and the Controlled Substances Act • Knowledge of Good Distribution Practice and current Good Manufacturing Practice principles • Knowledge of root cause analysis, quality risk management, data integrity, and audit or inspection readiness • Experience implementing, validating, or migrating electronic quality management systems • Strong technical writing, analytical, project leadership, communication, and organizational skills • Ability to manage competing priorities, use sound judgment, and work effectively across a large, matrixed organization • Knowledge of wholesale pharmaceutical distribution or pharmaceutical manufacturing • Proficiency with Microsoft Office applications and quality data analysis tools • Ability to work remotely while maintaining regular collaboration with distribution centers, Central Fill Pharmacy locations, and corporate partners • Ability to travel domestically, including occasional overnight travel, approximately 10% to 15% • Ability to work from home within approximately a two-hour drive of a USPD distribution center

🏖️ Benefits

• Annual bonus opportunity • Competitive compensation package • Long-term incentive opportunities may be offered • Benefits included in McKesson’s Total Rewards package • Remote work arrangement • Ability to work from home • Occasional domestic travel, approximately 10% to 15%

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