PBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. /ppbGeneral Description: /b /ppThe Senior Manager, Digital Quality Management Systems Business Analyst position is responsible for supporting and executing the strategy, implementation, and lifecycle management of digital Quality Systems. This role serves as a key liaison between Quality, IT, and business stakeholders, ensuring that technology solutions are aligned with business requirements, business goals, and industry best practices. The role balances traditional Quality Management System (QMS) responsibilities with cross-functional project leadership, system ownership, and process optimization to drive GxP compliance and enhance digital maturity. /ppbEssential Functions of the Job: /b /plipServe as the business System Owner for assigned Quality GxP digital systems (e.g., eQMS, QualityDocs, etc). /p /lilipLead and manage full lifecycle of system implementations and enhancements. /p /lilipGather and translate complex business needs into functional and technical requirements. /p /lilipDrive process mapping, continuous improvement, and digital transformation initiatives across Quality. /p /lilipCollaborate with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors to align systems with business strategy. /p /lilipDevelop and maintain strong relationships with business process owners and ensure systems meet evolving needs. /p /lilipPlan and lead UAT, training, and change management activities for new system features or implementations. /p /lilipManage project scope, timeline, resources, budgets, and risks, escalating issues as needed. /p /lilipEnsure ongoing system compliance with applicable GxP, FDA, EMA, and ISO standards. /p /lilipPrepare and deliver high-quality project updates, stakeholder communications, and system documentation. /p /lilipOversee the governance, configuration, and administration of digital quality tools such as Veeva QMS, ensuring alignment with organizational policies and compliance standards while optimizing system functionality to enhance user experience and operational efficiency. /p /lilipDevelop and implement master data management practices to ensure data accuracy, consistency, and integrity across digital quality tools, facilitating informed decision-making and compliance with regulatory requirements. /p /lilipPerform other duties, as assigned. /p /lipbEducation and Experience Required: /b /plipBachelor’s degree and 7+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment required of Master’s degree and 5+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment preferred /p /lipbSupervisory Responsibilities: /b /plipN/A /p /lipbComputer Skills: /b /plipProficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project). /p /lipbOther Qualifications: /b /plip7+ years of related experience in Quality Systems, project management, and business analysis /p /lilipStrong understanding of GxP requirements, Quality System Regulations (QSR), and validation practices. /p /lilipProven experience managing enterprise system implementations (e.g., Veeva Vault, SAP, etc.). /p /lilipExperience in business administration for Veeva QMS. /p /lilipSkilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation. /p /lilipExcellent interpersonal, communication, and organizational skills. /p /lilipLean Six Sigma or Agile certification preferred. /p /lipbTravel: /b Up to 15% /ppGlobal Competencies /ppWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. /pliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf-Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults-Oriented /liliAnalytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li