Senior Quality Operations Specialist

Responsibilities

• Operations Quality Support and Collaboration
• Serve as the primary Quality liaison to Operations at the Clermont DC
• Maintain a regular onsite presence to foster a culture of quality, compliance and collaboration
• Partner with cross‑functional stakeholders to address operational quality needs and risks
• Promptly escalate critical events while planning the investigative approach based on event risk, urgency, resource availability, and potential business impact
• Oversees critical investigation execution, coordinating cross‑functional input as needed to support timely and effective resolution
• Quality System Execution and Oversight
• Drive expectations for quality at the Distribution Center (DC) including, but not limited to:
• Create, review and/or edit Standard Operating Procedures (SOPs) and Work Instructions (WIs) to enhance operational efficiency and compliance with corporate policies and regulations
• Ensure operational compliance with DSCSA and implementation of National Standards
• Supports the administration and completion of operational investigations, while coaching teams on root cause analysis tools, and the appropriate development and implementation of CAPAs to ensure regulatory defensibility.
• Translates investigation data, trends, and business drivers into actionable recommendations that improve investigation outcomes and inspection readiness
• Identifies operational pain points and emerging risks and translates them into system or procedural improvements while maintaining operational efficiency
• Technical Resource Role
• Serve as the Subject Matter Expert (SME) in the following areas:
• Documentation Management / Version Control / Good Documentation Practices
• Change Control
• Investigations / Root Cause Analysis
• Corrective and Preventive Actions (CAPAs)
• Regulatory Inspection Management
• Validation
• Electronic Quality Management Systems (e.g. TrackWise and MasterControl)
• Data Integrity
• Quality Leadership, Coaching & Knowledge Development
• Partners with the site Director of Operations to support training delivery to enhance Operations' understanding and application of Quality principles and requirements
• Acts as a technical and process expert for less‑experienced colleagues, providing guidance during critical events, and offering

Benefits

Additional Information

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you. The Senior Quality Operations Specialist will serve as an individual contributor within the U.S. Pharmaceutical Distribution (USPD) Quality Team, providing quality and technical guidance to Operations. Reporting to the Director of Operations Quality, this role operates as a key contributor, independently and through project teams, to employ their knowledge and expertise to embed quality culture, reduce compliance risk, identify efficiencies, drive continuous improvement activities, and achieve business results. This role will ensure that processes, procedures, people, analytics and technology are being leveraged to maximize quality processes and compliance across the network. The Senior Quality Operations Specialist provides direction during high-risk and critical events that may have potential impact to product by applying their experience and judgement within defined policies. This individual will also influence investigation quality standards, documentation rigor, and work prioritization to promote consistent application of internal procedures and applicable regulatory requirements. In addition, the Senior Quality Operations Specialist supports the Director Operations Quality in maintaining the effectiveness of USPD's Quality Management System (QMS) in accordance with internal policies and applicable laws and regulations, including preparedness for emerging regulatory and operational changes. This role serves as an onsite technical resource to operational colleagues and cross‑functional partners without formal people‑management responsibility. Success in this role requires demonstrated expertise in regulated pharmaceutical distribution, ability to apply cGMP concepts (as appropriate) to varying types of supply chain operations, strong analytical judgment, and effective collaboration across multiple internal and external stakeholders in a highly matrixed environment. This is an onsite role located in Shepherdsville, KY (i.e. the Clermont Specialty DC). Compensation : Target salary for this role is between $128,000 and $130,000 along with a 20% bonus.

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