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Title: Sr. Manager Change Control

Location: Atlanta, GA; Columbus, OH; Dallas, TX (Preferred)

Remote / Onsite / Hybrid: Remote position

Position Summary

The Sr. Manager Change Control leads complex, cross-functional initiatives and serves as a subject-matter expert for assigned enterprise QMS processes, with primary accountability for Change Control. Working within the enterprise strategy, governance, policies, and priorities established by the Director, this role translates requirements into practical standards, implementation plans, technology-enabled workflows, performance measures, and sustainable operating practices across participating business units.

Key Responsibilities

1. Lead assigned QMS process initiatives

Lead the design, implementation, harmonization, and continuous improvement of assigned enterprise QMS processes, with primary responsibility for Change Control. Develop requirements, standards, procedures, controls, and implementation plans consistent with direction and governance established by the Director.

2. Provide subject-matter expertise and recommendations

Evaluate business-unit practices, regulatory requirements, process risks, and operational needs. Recommend practical solutions, decision options, and escalation paths to the Director, governance forums, and process owners.

3. Coordinate cross-functional implementation and adoption

Manage complex workplans, dependencies, risks, milestones, stakeholder engagement, communications, training, and readiness activities required to embed approved QMS changes across participating business units.

4. Support QMS technology and digital enablement

Define business and quality requirements for approved digital workflows, analytics, and automation supporting assigned QMS processes. Coordinate solution evaluation, user acceptance testing, validation documentation, deployment readiness, and lifecycle changes with Technology and control functions.

5. Establish and monitor process performance

Develop process measures, dashboards, and review routines for assigned QMS elements. Analyze trends, control effectiveness, adoption, and emerging risks; prepare actionable insights and recommendations for management review.

6. Facilitate governance and stakeholder alignment

Prepare materials and facilitate working sessions, communities of practice, and governance discussions. Track decisions and actions, resolve issues within delegated authority, and escalate matters requiring enterprise policy, funding, or strategic decisions.

7. Build capability and sustain improvements

Develop guidance, tools, education, and coaching for business-unit Quality teams and process owners. Share leading practices and support consistent execution while recognizing legitimate regulatory and operational differences.

Minimum Job Qualifications

Education and Training

• Bachelor's degree in quality, engineering, life sciences, business, information systems, or a related field, or equivalent relevant experience.
• Professional certification in quality, project management, change management, or process improvement is preferred, such as ASQ CQA/CMQ-OE, PMP, Prosci, or Lean Six Sigma.

Business Experience

• Minimum of 7 years of progressively responsible experience in Quality Management Systems within pharmaceuticals, medical devices, healthcare distribution, or another regulated industry.
• Demonstrated 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 is required.
• Experience supporting implementation or optimization of an electronic QMS is preferred.

Specialized Knowledge and Skills

• Strong working knowledge of QMS principles, process governance, risk-based decision-making, change management, and continuous improvement.
• Ability to translate enterprise direction into clear requirements, standards, procedures, workplans, controls, and measurable outcomes.
• 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 to Quality and business leaders.
• Strong facilitation, stakeholder management, written communication, project leadership, and issue-resolution skills.
• Working knowledge of data integrity, validation, privacy, cybersecurity, access control, and human oversight considerations for digital or AI-enabled Quality solutions.
• Ability to influence across functions and business units while operating within established enterprise governance and delegated decision rights.

Decision Rights and Scope Boundaries

• Leads assigned initiatives and recommends standards, controls, and implementation approaches; enterprise QMS strategy, policy approval, governance design, and final prioritization remain accountable to the Director and designated governance bodies.
• May serve as process lead or subject-matter expert for assigned QMS elements but does not independently establish enterprise strategy or approve organization-wide policy outside delegated authority.
• Coordinates cross-functional resources and vendors for approved initiatives; does not carry standing people-management accountability or independent enterprise budget ownership.
• Escalates material compliance risks, unresolved cross-business-unit conflicts, significant scope changes, and investment decisions to the Director.

Travel: up to 30%, based on implementation, stakeholder, and site-support needs.

Must be authorized to work in the US. Sponsorship is not available for this position.

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

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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 our Equal Employment Opportunity page.

 

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