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
Prepare and deliver high-quality project updates, stakeholder communications, and system documentation
Oversee the governance, configuration, and administration of digital quality tools such as Veeva QMS
Develop and implement master data management practices to ensure data accuracy, consistency, and integrity across digital quality tools

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
Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation
Excellent interpersonal, communication, and organizational skills.
Lean Six Sigma or Agile certification preferred.

Senior Manager, Digital Quality Management Systems, Business Analyst

Key skills