Senior Manager, Digital Quality Management Systems, Business Analyst

The 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., * 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, ensuring alignment with organizational policies and compliance standards while optimizing system functionality to enhance user experience and operational efficiency.
• Develop 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.
• Perform other duties, as assigned.

• Bachelor'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, * Proficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project)., * 7+ years of related experience in Quality Systems, project management, and business analysis
• 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.