McKesson

Senior Quality Specialist

McKesson • $108K — $181K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, Quality, Pharmacy, or related field, or equivalent experience.
  • 7+ years of experience in pharmaceutical manufacturing, distribution, healthcare, or other regulated environments.
  • Experience in Change Control processes within a Quality Management System (QMS).
  • Knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
  • Familiarity with pharmaceutical regulations and regulatory requirements.

Responsibilities

  • Serve as the primary quality resource for change control activities across operations.
  • Review change control records for completeness and compliance before approval.
  • Monitor open change controls and engage stakeholders for timely closure.
  • Verify completion of actions and supporting evidence prior to final approval.
  • Develop and maintain Standard Operating Procedures (SOPs) related to change control.
  • Support training and adoption of quality system requirements among users.
  • Analyze and communicate key quality metrics to management and stakeholders.

Benefits

  • Comprehensive benefits package including health, dental, and vision insurance.
  • Opportunities for professional growth and development.
  • Supportive work environment that promotes a culture of quality and compliance.
  • Access to performance-based bonuses and incentives.
Full Job Description
About the Role

McKesson is seeking a Senior Quality Systems Specialist to serve as a subject matter expert for Change Control processes within our Quality Management System (QMS). This role supports more than 30 pharmaceutical distribution centers and Central Fill Pharmacy locations, ensuring change control activities are compliant, appropriately assessed for risk, fully documented, and closed in accordance with quality and regulatory requirements.

The ideal candidate combines expertise in GMP/GDP-regulated environments with strong change control, quality systems, and stakeholder management experience. This position works cross-functionally to drive quality excellence, maintain compliance, and support operational effectiveness across the organization.

What You'll Do
  • Serve as the primary quality resource for change control activities across distribution and pharmacy operations.
  • Review and assess change control records for completeness, procedural compliance, risk assessment, and implementation readiness.
  • Monitor open change controls, identify potential delays, and partner with stakeholders to ensure timely completion and closure.
  • Verify completion of required actions, deliverables, and supporting evidence prior to final approval and closure.
  • Develop, revise, and maintain Standard Operating Procedures (SOPs) and work instructions related to change control processes.
  • Support training, communication, and adoption of change control procedures and quality system requirements.
  • Provide guidance to users of TrackWise and other electronic Quality Management Systems.
  • Lead or participate in change control communities of practice and continuous improvement initiatives.
  • Analyze and communicate key quality metrics, trends, and status updates to management and stakeholders.
  • Support internal audits, regulatory inspections, customer audits, and quality improvement projects as needed.
  • Collaborate with cross-functional teams to maintain compliance with FDA, DEA, state, and other applicable regulatory requirements.
  • Promote a culture of quality, compliance, accountability, and continuous improvement.

Basic Requirements
  • Bachelor's degree in Life Sciences, Engineering, Quality, Pharmacy, or another related technical field, or equivalent experience.
  • 7+ years of experience in pharmaceutical manufacturing, pharmaceutical distribution, healthcare, or other regulated environments.
  • Experience supporting or managing Change Control processes within a Quality Management System (QMS).
  • Working knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
  • Working knowledge of pharmaceutical regulations and regulatory requirements.
  • Experience coordinating and influencing cross-functional stakeholders to achieve business objectives.

Preferred Skills/Experience
  • Experience with TrackWise or similar electronic Quality Management Systems.
  • Knowledge of FDA, DEA, State Board of Pharmacy, and other applicable regulatory requirements.
  • Experience supporting distribution center, pharmacy, manufacturing, or supply chain quality operations.
  • Strong understanding of quality systems, change management, risk assessment, and compliance programs.
  • Experience developing SOPs, work instructions, and training materials.
  • Experience leading projects or quality initiatives without direct supervisory responsibility.
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent communication, collaboration, and stakeholder management abilities.
  • Experience using quality metrics, dashboards, and data analytics to drive improvements.
  • Demonstrated ability to work independently and effectively manage multiple priorities in a fast-paced environment.

Travel, Work Environment & Physical Requirements
  • Ability to travel domestically up to 10%.
  • Work may be performed in office, distribution center, warehouse, and Central Fill Pharmacy environments.
  • General office and computer-based work activities required.
  • Candidates must reside within a reasonable driving distance (approximately two hours or less) of a designated McKesson distribution center location.


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

$108,700 - $181,100

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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