Serve as the business System Owner for assigned Quality GxP digital systems (e.g., eQMS, QualityDocs, etc)
Lead and manage full lifecycle of system implementations and enhancements
Gather and translate complex business needs into functional and technical requirements
Drive process mapping, continuous improvement, and digital transformation initiatives across Quality
Collaborate with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors to align systems with business strategy
Develop and maintain strong relationships with business process owners and ensure systems meet evolving needs
Plan and lead UAT, training, and change management activities for new system features or implementations
Manage project scope, timeline, resources, budgets, and risks, escalating issues as needed
Ensure ongoing system compliance with applicable GxP, FDA, EMA, and ISO standards
Oversee the governance, configuration, and administration of digital quality tools such as Veeva QMS

Requirements

Bachelor’s degree and 7+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment required
Master’s degree and 5+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment preferred
Proficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project)
Strong understanding of GxP requirements, Quality System Regulations (QSR), and validation practices
Proven experience managing enterprise system implementations (e.g., Veeva Vault, SAP, etc.)
Experience in business administration for Veeva QMS
Lean Six Sigma or Agile certification preferred

Benefits

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

system implementationbusiness requirements gatheringprocess mappingchange managementproject managementsystem compliancevalidation practicesenterprise system managementdigital transformationquality system regulations

Soft Skills

collaborationrelationship managementleadershipcommunicationproblem-solvingorganizational skillsadaptabilitycritical thinkingteam managementstakeholder engagement

Certifications

Lean Six SigmaAgile certification