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.

Sr. Manager - Enterprise Quality Validation

Location: Remote

Medical device or Pharmaceutical experience (REQUIRED)

Travel Requirement: 30%-40%

McKesson seeks a leader to serve as a Sr. Manager - Enterprise Quality Validation for the Enterprise Quality Management function, reporting to the Sr. Director, Quality Management System Practices & Effectiveness. This new function provides validation and quality support for the wide variety of businesses within the McKesson enterprise. The Sr. Manager - Enterprise Quality Validation will manage and ensure validation procedures and practices are defined. The role will support the Enterprise Quality Team by leading and supporting validation learnings, workshops, trainings, and quality governance for validation and qualification of McKesson systems.

Scope of Responsibilities

Responsibilities for the Sr. Manager - Enterprise Quality Validation include, but are not limited to:

• Builds an enterprise validation program. Authoring and reviewing enterprise validation policies and procedures; leading review milestones, engaging stakeholders, and ushering through implementation.
• Provides oversight and guidance on validation/qualification strategies and climate control across McKesson Corporation business units.
• Develops best practices and industry standards for validation/qualification.
• Develops, leads, and supports validation training, learning, and workshop sessions.
• Drafts and executes validation plans, protocols, and reports.
• Coaches and mentors across McKesson to further validation knowledge and expertise.
• Supports Audits and Inspections when needed. This includes preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities.
• Stay current with applicable regulations and industry practices. Provide updates to business areas and update procedures and practices accordingly to align with current regulations and industry standards from BOP, FDA, ISO, EMA and any other applicable domestic and international regulation.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, and collaborating with stakeholders to achieve value for the businesses.

Candidate Profile

• Hands on, coaching, and motivated leader to drive risk reduction and maturity of the validation programs.
• Demonstrated ability to influence across a matrix structure, and to collaborate in a cross-functional environment.
• Highly organized and proficient in working in matrixed organization to support business and program needs.
• Provides motivational leadership to the organization and improve its performance.
• Strong interpersonal, verbal, and written communication skills, organizational and workload planning skills along with the ability to manage multiple different projects simultaneously.

Minimum Requirements:

• 10 years of validation experience, including minimum of 5 years hands on validation/qualification experience in pharmaceuticals, medical devices, or other FDA-regulated industries.
• Experience working within an operation site environment such as manufacturing, distribution, or pharmacy leading key areas Validation. Qualification of controlled product storage areas and chambers, such as refrigerators, freezers, stability, or warehousing experience a must. Computer Systems Validation experience preferred.
• Minimum Bachelor's degree in science or engineering required for this position, MBA and/or certifications are a plus.
• Strong compliance mindset and knowledge of validation/qualification regulations, practices, and expectations coupled with proficiency in an implementation approach for diverse businesses across McKesson Corporation.

• Demonstrated experience managing or supervising a validation group.
• Able to operate effectively in a highly matrixed environment. Problem-solver with the ability to translate qualitative and quantitative information into actionable recommendations.
• Able to inspire the trust, confidence, and respect of peers and other leaders.

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. 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, pleaseclick here.

Our Base Pay Range for this position

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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