Senior Manager – Change Control

McKesson

. Lead the design, implementation, harmonization, and continuous improvement of enterprise QMS processes, primarily Change Control .

Posted 11/10/2026full-timeUnited StatesSenior💰 $108,700 - $181,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) with a focus on Change Control, process improvement, and regulatory compliance within the pharmaceutical and healthcare sectors. Capable of leading cross-functional initiatives, analyzing data for trends, and providing actionable insights to enhance operational effectiveness.

Highest-signal resume keywords

Quality Management Systems (QMS)Change ControlProcess ImprovementRegulatory ComplianceData Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Change ControlDocument ManagementCAPARisk ManagementAuditsProcess GovernanceContinuous ImprovementData IntegrityValidationCybersecurity

Soft Skills

Stakeholder EngagementCommunicationProblem-SolvingFacilitationCoaching

Tools & Technologies

Electronic QMSAnalyticsAutomationDashboardsValidation Documentation

Certifications & Qualifications

Quality CertificationProject Management CertificationChange Management CertificationProcess Improvement Certification

Industry Keywords

PharmaceuticalsMedical DevicesHealthcare DistributionFDA RequirementsDEA Compliance

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Lead the design, implementation, harmonization, and continuous improvement of enterprise QMS processes, primarily Change Control
Develop requirements, standards, procedures, controls, and implementation plans
Evaluate business-unit practices, regulatory requirements, process risks, and operational needs
Recommend practical solutions, decision options, and escalation paths
Manage complex workplans, dependencies, risks, milestones, stakeholder engagement, communications, training, and readiness activities
Define business and quality requirements for digital workflows, analytics, and automation
Coordinate solution evaluation, user acceptance testing, validation documentation, deployment readiness, and lifecycle changes
Develop process measures, dashboards, and review routines; analyze trends and control effectiveness
Prepare insights and recommendations for management review
Facilitate working sessions, communities of practice, and governance discussions
Track decisions and actions, resolve issues, and escalate matters requiring enterprise decisions
Develop guidance, tools, education, and coaching for Quality teams and process owners
Coordinate cross-functional resources and vendors for approved initiatives
Travel up to 30% based on implementation, stakeholder, and site-support needs

Requirements

What you’ll need

Bachelor's degree in quality, engineering, life sciences, business, information systems, or a related field, or equivalent relevant experience
Minimum of 7 years of progressively responsible experience in Quality Management Systems within pharmaceuticals, medical devices, healthcare distribution, or another regulated industry
Experience leading complex, cross-functional process improvement or implementation initiatives without direct authority over all participants
Experience with Change Control, document management, CAPA, training, risk management, audits, or related QMS processes
Deep expertise in at least one enterprise QMS process
Strong working knowledge of QMS principles, process governance, risk-based decision-making, change management, and continuous improvement
Knowledge of applicable FDA requirements and familiarity with DEA, state Board of Pharmacy, and other requirements relevant to pharmaceutical distribution, as appropriate
Ability to analyze data, identify trends and control gaps, and present concise recommendations
Working knowledge of data integrity, validation, privacy, cybersecurity, access control, and human oversight considerations for digital or AI-enabled Quality solutions
Must be authorized to work in the US
Sponsorship is not available for this position
Professional certification in quality, project management, change management, or process improvement is preferred
Experience supporting implementation or optimization of an electronic QMS is preferred

Benefits

Comp & perks

Competitive compensation package
Annual bonus or long-term incentive opportunities may be offered
Benefits as part of McKesson’s Total Rewards