Senior Quality Systems Specialist – Change Control Leader

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 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