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Job description
McKesson seeks an Enterprise Quality Validation Engineer for the Enterprise Quality Management function, reporting to the Sr. Director, Enterprise QMS and Quality Engineering. This new function provides validation support for a wide variety of businesses within the McKesson enterprise.
The Enterprise Quality Validation Engineer will ensure software systems used in regulated environments comply with FDA requirements and other applicable guidance, including data integrity and 21 CFR Part 11.
Scope of Responsibilities
Plans, executes, and documents validation/qualification activities to ensure software systems are fit for their intended use, maintaining data integrity, reliability, and compliance.
Drafts and executes validation plans, protocols, and reports. Develops and executes software validation protocols (IQ, OQ, PQ) in accordance with risk levels, FDA expectations, and industry standards.
Creates and maintain validation documentation including plans, scripts, traceability matrices, summary reports, and inventory lists.
Conducts risk assessments and impact analyses for software systems.
Collaborates with cross-functional teams (QA, IT, Engineering, Regulatory) to ensure validation efforts are commensurate with risk rankings, aligning with business and compliance needs.
Reviews and approve validation deliverables from internal teams and third-party vendors.
Provides guidance on validation/qualification strategies and across McKesson Corporation business units.
Participates and supports validation training, learning, and workshop sessions.
Supports Audits and Inspections when needed. This includes preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities.
Stays 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 regulations.
Candidate Profile
Hands on, coaching, and collaborative work style.
Demonstrated ability to communicate across a matrix structure and facilitate in a cross-functional environment.
Highly organized and proficient in working in matrixed organization to support business and program needs.
Strong interpersonal, verbal, and written communication skills, with the ability to manage multiple different projects simultaneously.
Minimum 3 years of software validation experience in pharmaceuticals, medical devices, or other FDA-regulated industries.
Minimum Bachelor’s degree in science or engineering required for this position.
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 leaders.
Minimum Education & Experience
Degree or equivalent and typically requires 4+ years of relevant experience.
Must be authorized to work in the US. Sponsorship is not available for this position.
Hub locations: Atlanta, GA; Columbus, OH; Dallas, TX; Richmond, VA
Hybrid/Remote/Onsite: REMOTE
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Worksite address
dallas, TX, 75215, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.