McKesson

Sr. Director Quality, Investigations/CAPA/Recall

McKesson • $181K — $301K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
  • Over 13 years in quality assurance roles, with 6 years in management.
  • Strong leadership and people motivation skills.
  • Extensive knowledge of drug product regulations and FDA, DEA, and State Board of Pharmacy requirements.
  • Deep understanding of supply chain operations in pharmaceutical settings.
  • Expertise in Investigation, CAPA, and Recall programs, with strategy development skills.
  • Proven track record in managing complex quality investigations and execution of recalls.

Responsibilities

  • Lead strategic direction for quality programs related to Investigations, CAPA, and Recalls across Supply Chain Operations.
  • Develop and implement operational processes and budget expectations for relevant quality programs.
  • Engage with senior leadership to translate organizational strategy into quality strategy and ensure effective investigations and CAPAs.
  • Oversee Quality Investigations and CAPA efforts, representing Quality during audits and facilitating corrective actions.
  • Provide expertise to ensure compliance with regulatory expectations and promote understanding of the quality strategy among stakeholders.
  • Establish and monitor key performance indicators (KPIs) for investigations and CAPA processes, reporting on trends to management.
  • Drive continuous improvement initiatives for the Quality Management System, fostering a positive team environment.

Benefits

  • Remote position with proximity requirement to Washington D.C.
  • Travel required up to 25%.
  • Competitive compensation package including potential bonuses and long-term incentives.
Full Job Description
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).


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

$181,100 - $301,900

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.

About McKesson

McKesson Corporation provides medicines, pharmaceutical supplies, information and care management products and services across the healthcare industry. The Company operates in two segments. The McKesson Distribution Solutions segment delivers ethical drugs, medical-surgical supplies and equipment and health and beauty care products throughout North America. This segment also provides specialty pharmaceutical solutions for biotech and pharmaceutical manufacturers, sells financial, operational and clinical solutions for pharmacies (retail, hospital, long-term care) and provides consulting, outsourcing and other services. The McKesson Technology Solutions segment delivers enterprise-wide clinical, patient care, financial, supply chain, strategic management and software solutions. In July 2011, the Company acquired Portico Systems from Safeguard Scientifics, Inc. On March 25, 2012, it acquired the independent banner and franchise businesses of Katz Group Canada Inc. McKesson Distribution Solutions delivers pharmaceuticals to retail pharmacies and institutional providers like hospitals and health systems. They operate pharmaceutical distribution centers across the country, serving customers in all 50 states. They also deliver a comprehensive offering of health care products, technology, equipment and related services to the alternate site market, including physician offices, surgery centers, long-term care facilities and home care businesses across the country. McKesson is currently the largest pharmaceutical distributor in North America. McKesson also operates McKesson Canada and has an equity holding in Nadro, a leading distributor in Mexico.

McKesson Careers

Join McKesson, a leading global healthcare company, and be part of a team that is redefining the future of healthcare. With a variety of job opportunities available, McKesson is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At McKesson, we are committed to improving care in every setting—one product, one partner, one patient at a time. We’re seeking talented professionals to join our team and contribute to a culture of innovation, diversity, and leadership. Our employees are driven by a deep sense of purpose and a desire for continuous growth and improvement. Empower Your Future in Healthcare With positions ranging from internships to leadership roles, McKesson offers unparalleled employment opportunities to develop your skills and advance your career. Our commitment to diversity training ensures that all team members have the opportunity to thrive. Join a team where your skills will be honed, your professional growth will be supported, and where you can genuinely see the difference you make in the lives of patients around the world. Innovative Work Environment McKesson is at the forefront of healthcare innovation. Our team is constantly exploring new ways to improve patient outcomes and streamline care processes. This commitment to innovation is what sets us apart and what makes McKesson an exciting place to work. Career Development and Benefits McKesson believes in nurturing the potential of its employees through robust career development programs and comprehensive benefits designed to support your life and well-being. From leadership training to health and wellness benefits, we ensure our team members are equipped to meet their professional and personal goals. Explore Job Opportunities Whether you’re looking for an internship to kickstart your career, or a senior position to utilize your extensive experience, McKesson offers a range of opportunities. Explore our open positions and find where you can make a difference at McKesson. Stay Connected Join Our Team Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take the next step in their careers. Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Networking and Professional Growth At McKesson, networking and professional growth are part of our everyday environment. We encourage our employees to connect, share, and learn from each other to foster personal and professional development. Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await you at McKesson. Join McKesson today and be part of a team that is dedicated to shaping the future of healthcare.
Learn more about McKesson
Size
58,000 employees
Market Cap
$53.7 billion
Industry
Pharmaceuticals & Biotech
Net Income
-$4.1 billion
Founded
1833
5 Year Trend
+5.9%
Revenue
$237.6 billion
NASDAQ
MCK
* Ladders Estimates

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