Senior Quality Systems Lead: Change Control & Compliance

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

Job summary

McKesson seeks a Senior Quality Systems Specialist to serve as the SME for change control within our Quality Management System across distribution centers and Central Fill locations. You will drive risk assessments, maintain SOPs, and support audits to ensure compliant, timely change management in a regulated environment.

The role requires strong TrackWise expertise, GMP/GDP knowledge, and proven stakeholder management across teams, with travel up to 10% as needed.

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 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.

Responsibilities

• Serve as the primary quality resource for change control activities across distribution and pharmacy operations.
• Review and assess change control records for completeness, compliance, risk, and readiness.
• Monitor open change controls and partner with stakeholders to ensure timely closure.
• Verify required actions and evidence prior to approval and closure.
• Develop and maintain SOPs and work instructions related to change control.
• 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.
• Collaborate with cross-functional teams to maintain compliance with FDA, DEA, state, and other regulatory requirements.
• Promote a culture of quality, compliance, accountability, and continuous improvement.

Skills

Cross-functional collaboration

Analytical skills

Communication skills

Problem-solving

Stakeholder management

Education

Bachelor's degree or higher in Life Sciences/Engineering/Quality/Pharmacy

Tools

TrackWise

Job description

McKesson seeks a Senior Quality Systems Specialist to serve as the SME for change control within our Quality Management System across distribution centers and Central Fill locations. You will drive risk assessments, maintain SOPs, and support audits to ensure compliant, timely change management in a regulated environment.

The role requires strong TrackWise expertise, GMP/GDP knowledge, and proven stakeholder management across teams, with travel up to 10% as needed.