[Hiring] Senior Quality Specialist @McKesson

Role Description

The Senior Quality Specialist handles complex quality issues across US Pharmaceutical Distribution. The role leads investigations, temperature excursion reviews, and corrective and preventive actions (CAPA), and supports recalls and product disposition decisions. This person is expected to work independently, use sound judgment, and be a trusted resource for colleagues and business partners. The position also helps improve quality systems and maintain compliance across the distribution network.

Key Responsibilities

• 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.
• Looks for practical ways to improve quality processes and electronic quality management systems. Works with the appropriate teams to simplify processes, strengthen compliance, and improve the quality of data and documentation.
• Provides technical guidance on investigations, recalls, CAPAs, quality risk assessments, and product disposition decisions. Helps colleagues work through difficult issues and serves as a resource when additional expertise is needed.
• Leads cross-functional projects involving Operations, Compliance, distribution centers, Technology, and external partners. Keeps stakeholders informed, resolves issues, and makes sure agreed actions are completed.
• Reviews investigation data, metrics, and trends to identify recurring problems or broader risks. Recommends corrective or preventive action and explains the findings to business and quality leaders.
• Applies relevant 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 to help others strengthen their investigation and quality-system skills.

Qualifications

• 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.

Requirements

• 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. Able to explain technical issues clearly and work effectively with different teams.
• 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 to support investigations, audits, and quality initiatives.
• 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

• Competitive compensation package as part of Total Rewards.
• Base pay range for this position: $103,500 - $172,500.
• Opportunity for an annual bonus or long-term incentive opportunities.