Senior Director Quality, Investigations/CAPA/Recall

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.

Company Profile

McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments, and other organizations in healthcare to help provide the right medicines, medical products, and healthcare services to the right patients at the right time, safely and cost-effectively.

United by our I2CARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful - all for the better health of patients. McKesson has been named a “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more info, visit www.mckesson.com.

We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us.

Role Overview

McKesson is seeking a Sr. Director Quality, Investigations/CAPA/Recall.

The Sr. Director Quality, Investigations/CAPA/Recall is responsible for leading the strategy, development, and execution of the Quality Management System programs related to Investigations, Corrective and Preventive Actions (CAPA), and Recalls across U.S. Pharmaceutical Distribution. This role ensures that procedures, analytics, technology, and governance are effectively implemented and leveraged to drive compliance, operational efficiency, and sustainable quality improvement across distribution centers and Central Fill Pharmacy locations. This role is critical in safeguarding product quality, patient safety, and regulatory adherence.

Job Responsibilities

• Provides strategic leadership and direction for Investigation, CAPA, Recall, Complaint, Quarantine, and related quality programs across Supply Chain Operations. The role is accountable for establishing multi-year roadmaps, long-term goals, process capabilities, performance standards, and operating expectations for these quality system elements. The Senior Director provides professional, technical, and thought leadership across the Quality Management System and analyzes external business and regulatory trends to anticipate risk, influence strategy, and support continued compliance.

• Develops and implements operational processes, procedures, goals, metrics, and budget expectations for the Investigation, CAPA, and Recall programs. This role leads second-level and first-level managers and is accountable for the performance, services, and outcomes of the Quality Investigations, CAPA, and Recall teams. The position ensures manager accountability, supports team effectiveness, and manages the applicable budget, including resources associated with electronic quality management systems.

• Regularly engages with senior leadership and cross-functional stakeholders on matters impacting multiple functional areas and business units. The Senior Director translates organizational strategy into functional quality strategy and partners closely with U.S. Pharmaceutical Distribution leadership, Enterprise Quality, Supply Chain Operations, and other teams to ensure investigations and CAPAs are timely, thorough, risk-based, and effective in driving meaningful and sustainable improvement. The role also partners with the business to support prompt and appropriate response to recall scenarios.

• Serves as the lead for Quality Investigations and CAPA across Supply Chain Operations, including distribution centers and Central Fill Pharmacy locations. The role provides oversight for multiple related sub-functions, including product quality investigations, suspect and illegitimate product investigations, cold chain investigations, complaints, CAPA, externally initiated and company-initiated recalls, and quarantine activities. The position represents Quality during regulatory and customer audits, project teams, quality initiatives, business initiatives, investigation processes, and related programs, and facilitates corrective actions associated with audit findings.

• Works on highly complex issues that require an in-depth understanding of operations, quality systems, regulatory expectations, and established business processes. The Senior Director provides expertise and leadership to ensure activities and quality systems support compliance with applicable requirements, including sound scientific practice, data integrity principles, the Drug Supply Chain Security Act, applicable current Good Manufacturing Practices, standard operating procedures, and other relevant regulatory expectations. The role influences stakeholders to understand, support, and comply with the quality strategy and reviews or approves documentation as applicable, including investigations, CAPA, recalls, quality agreements, qualifications, and validations.

• Establishes and monitor key performance indicators (KPIs) for investigations, CAPA, and recall processes, reporting on trends, effectiveness, and compliance to senior management.

• Drives continuous improvement of the Quality Management System, with a focus on strengthening Investigation, CAPA, and Recall programs to address quality issues quickly and effectively. This role promotes a positive working environment by providing clear direction, communicating the quality strategy, and supporting alignment across teams.

Job Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or other technical/equivalent field experience required, advanced degree preferred.

• Minimum of 13 years of progressive experience in professional quality assurance roles in pharmaceutical manufacturing, pharmaceutical distribution, healthcare, or another highly regulated environment, including at least 6 years of direct people management experience.

• Demonstrated leadership, planning, communication, organization, and people motivation skills.

• Extensive knowledge of and practical experience with drug product regulations and detailed knowledge of FDA, DEA, State Board of Pharmacy, and other applicable regulatory requirements.

• Deep understanding of end-to-end supply chain operations across pharmaceutical manufacturing, distribution centers, third-party logistics providers, and pharmacies.

• Strong expertise in Investigation, CAPA, and Recall programs, including relevant industry standards and the ability to develop strategy and drive the development, implementation, and enforcement of processes and procedures to assure quality.

• Proven track record of successfully managing complex quality investigations, implementing effective CAPA, and executing product recalls.

• Excellent influencing, collaboration, and communication skills, with the ability to advise and guide business leaders on quality-related matters and collaborate effectively at all levels of the organization and with external stakeholders.

• Strong critical-thinking, systems-thinking, problem-solving, decision-making, organizational, and planning skills.

• Ability to work effectively in a highly matrixed environment, manage multiple priorities, and adapt to changing business needs.

• Strong digital literacy, including effective use of electronic quality management systems, analytics, dashboards, and digital tools to support insight, decision-making, and continuous improvement.

• Experience in managing and developing high-performing teams.

Working Environment

• This role is a remote position and the individual must live in close proximity to Washington D.C.

• Ability to travel domestically as required (up to 25% travel).

• Authorized to work in the United States without sponsorship. McKesson complies with all applicable U.S. immigration laws and regulations. The Company does not provide employer support or sponsorship for any immigration related employment benefit for this role. Applicants must be currently authorized to work in the United States on a fulltime basis without the need for employer support or sponsorship now or in the future. This includes having the legal right to work in the United States without the need for McKesson support or sponsorship for any immigration related employment authorization (e.g., H1B, O1, E3, H1B1, TN, F1 OPT, F1 STEM OPT, F1 CPT, etc.) now or in the future. If you will require McKesson to provide immigration support or sponsorship now or in the future, you should not apply for this position.

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!