Senior Quality Specialist

McKesson; Irving (TX); On-site; USD 109,000 - 181,000; Full time

Job summary

McKesson is seeking a Senior Quality Systems Specialist to act as a subject matter expert for Change Control within our QMS, supporting 30+ pharmaceutical distribution centers and Central Fill locations, ensuring change activities are compliant, risk-assessed, documented, and closed per quality and regulatory requirements.

The ideal candidate has GMP/GDP experience, strong change control, quality systems, and stakeholder management skills, with cross-functional collaboration to drive quality

Qualifications

• 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 GMP and GDP."
• Experience coordinating and influencing cross-functional stakeholders to achieve business objectives.

Responsibilities

• Serve as the primary quality resource for change control 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 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.

Skills

Stakeholder management

Analytical skills

Problem-solving

Communication

Collaboration

Decision-making

Education

Bachelor's degree

Tools

TrackWise

Job description

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.

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 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 the 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) [e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.

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