Quality Specialist - eQMS

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.

Title: Quality Specialist - eQMS

Remote/Hybrid/Onsite: REMOTE

Principal resource and subject matter expert on eQMS projects and initiatives. Interprets and translates high-level business and system requirements into project plans and configuration specifications. Manages eQMS projects, from the design process through a finished state. Prepares communications and makes presentations on project status and progress. Evaluates new eQMS developments and evolving business requirements and recommends appropriate systems alternatives and/or enhancements to current systems. Supports system validation activities. Complete administrative tasks in eQMS, as assigned. Ensures compliance with all governing procedures.

Key Responsibilities:

1. Serve as the principal resource on eQMS projects to gather and interpret business/system requirements and design new solutions. Responsible for translating business/system requirements and solution designs into configuration specifications. Works mostly independently on medium-to-high complexity projects and is capable of navigating ambiguities with minimal or no direction.

2. Conduct structured analysis on eQMS, and recommend changes (e.g. new modules, features, processes/functionality, settings/configurations). Present high-level benefits of

recommendation and explain rationale for selection over alternative solutions. Lead initiatives to implement changes/new solutions.

3. Responsible for the development/implementation of an eQMS project, from the design process through a finished state. Provides a single point of contact for projects and is responsible to take projects from original concept through final implementation.

4. Responsible for coordinating and conducting project meetings, capturing meeting notes, following-up on action items, and escalating roadblocks to appropriate contacts for resolution.

5. Oversee/coordinate all aspects of project and serves as project manager between internal/external customers, systems, and other departments. Plans and directs project schedules. Create detailed reports to communicate project status/progress to stakeholders and leadership.

6. Support system validation activities, including writing and/or collaborating on test scripts/protocols and executing validation testing.

7. Complete administrative tasks in eQMS, as assigned (e.g. respond to end-user inquiries submitted through ticketing system, quality reviews, training releases, document releases, archive/obsolete requests, deletion requests). Ensure compliance with the governing procedures.

Minimum Job Qualifications

Education/Training:

• Bachelor degree or equivalent experience

• Typically requires 4+ years of professional experience

Business Experience:

• 4 years of experience in a regulated environment implementing/supporting Quality System regulations 

• Some knowledge of FDA regulations (esp. 21 CFR Part 11) and ISO standards a plus

• 2 years administrator experience with quality management software systems

• 4 years of experience managing projects.

• Experience with managing technical projects a plus

Specialized Knowledge & Skills Requirements:

• Ability to interpret and translate business requirements into project plans and technical specifications

• Ability to provide clear and concise communication (both written and verbal)

• Ability to openly communicate appropriately to all levels of the organization, ability to motivate teams, and ensure ongoing and open communication.

• Develop and maintain strong relationships and communicate effectively with all project stakeholders, including partner champions and project team members in a timely and consistent manner 

• Expertise in eQMS systems (i.e. Maste