Senior Quality Specialist

🔥 12 hours ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $135k - $140k / year

⏰ Full Time

🟠 Senior

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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

• Leads complex product quality investigations, temperature excursion reviews, CAPAs, and critical-event activities • Determines the best approach, evaluates risk, identifies root cause, and documents clear, well-supported conclusions • Improves quality processes and electronic quality management systems • Works with teams to simplify processes, strengthen compliance, and improve quality of data and documentation • Provides technical guidance on investigations, recalls, CAPAs, quality risk assessments, and product disposition decisions • Leads cross-functional projects involving Operations, Compliance, distribution centers, Technology, and external partners • Keeps stakeholders informed, resolves issues, and ensures agreed actions are completed • Reviews investigation data, metrics, and trends to identify recurring problems or broader risks • Recommends corrective or preventive action and explains findings to business and quality leaders • Applies FDA requirements, 21 CFR, the Drug Supply Chain Security Act, United States Pharmacopeia standards, Good Distribution Practice, current Good Manufacturing Practice, and internal procedures • Supports audits, inspections, and readiness activities • Develops training, shares lessons learned, and provides mentoring and technical support

🎯 Requirements

• Degree or equivalent and typically requires 7+ years of relevant experience • Bachelor's degree in science, engineering, pharmacy, quality, or a related field, or equivalent experience • At least 7 years of experience in pharmaceutical quality, investigations, CAPA, recalls, regulated distribution, cold-chain operations, quality systems, or another regulated environment • Experience independently handling complex quality or compliance issues and making risk-based decisions using sound technical judgment • Experience leading projects and influencing decisions across teams without direct authority • Strong knowledge of investigation methods, root cause analysis, CAPA, quality risk management, product disposition, data integrity, and audit or inspection readiness • Working knowledge of applicable FDA regulations, 21 CFR, the Drug Supply Chain Security Act, Good Distribution Practice, current Good Manufacturing Practice, and relevant United States Pharmacopeia standards • Experience using electronic quality management systems and working with quality data, technical documents, and process improvements • Strong writing, communication, presentation, and organizational skills • Ability to manage several priorities, recognize when an issue needs to be escalated, and work with limited supervision • Ability to work primarily from a remote location and collaborate regularly with distribution centers, cross-functional teams, and corporate partners • Ability to occasionally work in distribution center, operational, or warehouse environments • Ability to travel domestically, including occasional overnight travel, up to 10% • Ability to work for extended periods at a computer and review detailed electronic records, data, and quality documentation

🏖️ Benefits

• Annual bonus opportunity • Competitive compensation package • Long-term incentive opportunities may be offered • Total Rewards package • Reasonable accommodation for job search or application

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