Sr. Director Quality, Investigations​/CAPA​/Recall

Sr. Director Quality, Investigations/CAPA/Recall

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.
• Develops and implements operational processes, procedures, goals, metrics, and budget expectations for the Investigation, CAPA, and Recall programs.
• Regularly engages with senior leadership and cross-functional stakeholders on matters impacting multiple functional areas and business units.
• Serves as the lead for Quality Investigations and CAPA across Supply Chain Operations, including distribution centers and Central Fill Pharmacy locations.
• Works on highly complex issues that require an in-depth understanding of operations, quality systems, regulatory expectations, and established business processes.
• 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.

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 with the 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.

Our Base Pay Range for this position

$181,100 - $301,900