Quality System Specialist

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 tomorrows health today we want to hear from you.

The eQMS System Administrator is responsible for the configuration validation and ongoing administration of the electronic Quality Management System (eQMS). This role serves as the technical and process owner for quality system workflows ensuring they are compliant validated userfriendly and aligned with regulatory requirements and business needs.

The eQMS System Administrator partners closely with Quality Regulatory IT and crossfunctional stakeholders to develop and maintain workflows for Complaints CAPA Change Control Training Document Control Audits Supplier Quality Controlled Substances and Risk Management. This role also owns quality system reporting KPIs and dashboards to support Management Review and continuous improvement initiatives.

Key Responsibilities

eQMS Administration & Governance

• Serve as the eQMS System Administrator and Business Process Owner for quality system workflows.

• Configure maintain and optimize eQMS modules workflows forms user roles and permissions.

• Ensure system configuration aligns with approved SOPs regulatory expectations and data integrity principles.

• Act as primary liaison between Quality and IT for eQMS-related issues enhancements and upgrades.

• Support system access management periodic access reviews and audit readiness activities.

Workflow Development & Validation

• Develop configure and maintain validated eQMS workflows including: Complaints CAPA Change Control Training Document Control Audits Supplier Quality Controlled Substances Risk Management

• Author and execute system validation documentation (e.g. URS FRS IQ/OQ/PQ validation summaries).

• Assess impact of system changes and support change control activities related to the eQMS.

• Ensure workflows support traceability escalation approvals and regulatory reporting requirements.

Reporting Metrics & Dashboards

• Design develop and maintain QMS reports KPIs and dashboards to support:

  • Management Review

  • Quality performance monitoring

  • Trending and risk identification

• Track and trend quality system metrics (e.g. CAPA aging complaint trends training compliance audit findings).

• Analyze data to identify systemic issues and continuous improvement opportunities.

• Present quality system performance data to Quality leadership and crossfunctional stakeholders.

SME Support General Quality Systems SME Support

• Provide general quality systems SME support (e.g. Document Control CAPA Supplier Quality Validation Change Control etc.).

• Ensure procedures and document workflows comply with document control SOPs and regulatory expectations.

• Support QMS training programs including role-based training assignments and effectiveness tracking.

• Provide end-user support and troubleshooting related to eQMS workflows and reporting.

Audit & Compliance Support

• Support internal customer and regulatory audits by providing eQMS records reports and system evidence.

• Ensure eQMS configuration supports compliance with applicable regulations and standards (e.g. FDA ISO).

• Participate in inspection readiness activities related to electronic records and data integrity.

• Support continuous improvement of quality system processes and system usability.

Additional Responsibilities

The above statements describe the general nature and level of work being performed. Additional responsibilities may be assigned as required.

Experience Required

• Minimum 46 years of experience in Quality Systems Quality Assurance or regulated systems administration.

• Hands-on experience administering and validating an eQMS in a regulated industry (medical device pharmaceutical or combination products).

• Experience developing workflows and reporting for multiple quality system processes.

Education

Bachelors degree in science engineering information systems or a related field.

Specialized Knowledge/Skills

• Strong understanding of regulated quality systems and electronic records requirements.

• Working knowledge of FDA regulations (e.g. 21 CFRPart 11) and ISO standards (e.g. ISO 13485 ISO 14971).

• Experience with system validation and change control.

• Strong analytical reporting and data visualization skills.

• Excellent written and verbal communication skills.

• High attention to detail with strong organizational and planning skills.

• Ability to work crossfunctionally and manage multiple priorities.

PC/Equipment

• Proficient in MS Office or the Google Platform

• Experience with eQMS platforms and reporting tools.

Work Environment/Physical Demands

• General office or remote work environment.

• Availability to support audits and system activities during U.S. business hours.

• Limited travel may be required.

About McKesson Medical-Surgical
McKesson Medical-Surgical (MMS) is a subsidiary and publicly reported segment of the McKesson Corporation. MMS distributes medical-surgical supplies pharmaceuticals diagnostic equipment and supplies along with other solutions and services to virtually every type of healthcare setting and provider outside of the traditional hospital. These markets often referred to as Alternate Care or Non-Acute Care include physician offices surgery centers long-term care providers laboratories home health and hospice agencies health systems government facilities and online marketplaces and retailers.

Alternate Care markets are growing rapidly and MMS is proud to be a leader in this space. With a team of approximately 8000 employees a network of 15 distribution centers and approximately 900 delivery vehicles we partner with more than 2200 leading manufacturers and serve over 200000 customer accounts across the U.S. Our catalog includes more than 280000 SKUs of branded and private-label medical-surgical products from bandages to specialty pharmaceuticals and COVID-19 tests.

Looking Ahead: A New Chapter for MMS
McKesson has announced its intent to separate MMS into an independent company by taking it public through an initial public offering (IPO). The separation could be completed by the second half of calendar year 2027 pending market factors and regulatory approvals. This is an exciting evolution that builds on MMSs strong foundation and proven leadership in the Alternate Care space. As a standalone company MMS would be positioned to unlock new opportunities to innovate grow and lead with even greater agility and focus. We will also continue to be one of the largest medical-surgical distributors in the U.S. with over$11B in annual separation would accelerate our mission and empower us to shape a future defined by customer-centricity bold thinking and operational excellence. For job seekers its a unique moment to join a team thats already making a meaningful impact and leading the way in shaping the future of healthcare delivery in Alternate Care settings with even greater opportunity ahead as we prepare to become an independent company.

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 McKessons 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 pleaseclick here.

Our Base Pay Range for this position

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKessons (or affiliated entities like CoverMyMeds or RxCrossroads) name in fraudulent emails job postings or social media light of these scams please bear the following in mind:

McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: .

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 McKessons full Equal Employment Opportunity policies visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment please contact us by sending an email to (United States) or (Canada) . Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!