[Hiring] Senior Manager, Quality Investigation/CAPA @McKesson

Role Description

The Senior Manager, Quality Investigation/CAPA leads the US Pharmaceutical Distribution team responsible for quality investigations, temperature excursions, corrective and preventive actions (CAPA), and suspect or illegitimate product reviews. The manager provides day-to-day direction, technical guidance, and coaching to help the team complete accurate, timely, and risk-based work. This role also supports quality systems, regulatory compliance, and continuous improvement across the distribution network.

Key Responsibilities

• Leads and develops the Investigation/CAPA team. Sets priorities, assigns work, monitors workload and performance, and provides regular coaching and feedback.
• Ensures investigations, CAPAs, regulatory notifications, trend reports, and self-audits are completed on time and meet quality requirements.
• Keeps Investigation/CAPA processes current and practical. Updates procedures, work instructions, training, and tools.
• Provides oversight for complex product quality investigations, temperature excursions, complaints, quarantines, critical events, and suspect or illegitimate product cases.
• Guides investigation strategy, root cause analysis, risk assessment, escalation, product disposition support, and final conclusions.
• Implements approved improvements to quality systems and processes, including electronic quality management system updates and standardized tools.
• Tracks investigation and CAPA performance, including aging, timeliness, effectiveness, and recurring trends.
• Ensures the team consistently applies FDA, DEA, Drug Supply Chain Security Act, Good Distribution Practice, current Good Manufacturing Practice, data integrity, and internal quality requirements.
• Partners with Enterprise Quality, Operations, distribution centers, Transportation, Recall, Global Security, and other groups to resolve issues.
• Represents Quality on audits, inspections, projects, and cross-functional initiatives.
• Manages the team’s approved operating expenses, including applicable electronic quality management system costs.

Qualifications

• Degree or equivalent experience. Typically requires 9+ years of professional experience and 1+ years of supervisory and/or management experience.
• Bachelor's degree in Engineering, Life Sciences, or a related field.

Requirements

• 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, with demonstrated ability to set expectations, manage performance, coach employees, and build team capability.
• Experience leading complex investigations and CAPAs, assessing risk, resolving quality or compliance issues, and driving timely, effective outcomes.
• Working knowledge of applicable FDA requirements, including 21 CFR and the Drug Supply Chain Security Act, as well as applicable DEA requirements and the Controlled Substances Act.
• Knowledge of Good Distribution Practice and current Good Manufacturing Practice principles, 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

• Competitive compensation package.
• Base pay range: $106,500 - $177,500.
• Annual bonus opportunity.