Senior Manager, Quality Investigation/CAPA

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 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.

Compensation: The salary for this role is targeted between $140,000 and $145,000 yearly with an annual bonus opportunity.

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 so the Quality team and distribution centers follow a consistent approach.
• 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. Works with affected USPD teams and locations to put changes into practice.
• Tracks investigation and CAPA performance, including aging, timeliness, effectiveness, and recurring trends. Shares findings with leadership and adjusts priorities or starts corrective action when needed.
• 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. Presents technical information clearly, coordinates assigned work, and follows through on commitments.
• Manages the team’s approved operating expenses, including applicable electronic quality management system costs.

Minimum Requirement

Degree or equivalent experience. Typically requires 9+ years of professional experience and 1+ years of supervisory and/or management experience.

Education

Bachelor's degree in Engineering, Life Sciences, or a related field.

Critical Skills

• 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.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:

McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: careers.mckesson.com.

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) Disability_Accommodation@McKesson.com or (Canada) Accessibility@mckesson.ca. Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!