"Alerted.org

**General Description:** This position supports and executes the strategy, implementation, and lifecycle management of digital Quality Systems. The **Senior Manager, Digital Quality Management Systems** acts 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 QMS responsibilities with cross-functional project leadership, system ownership, and process optimization to drive GxP compliance and 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/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.

+ Perform other duties, as assigned

Skills and Qualifications:

+ Bachelor’s degree in Science, Engineering, Information Systems, or related field; or equivalent experience.

+ 7+ years of experience in a regulated life sciences environment.

+ 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.).

+ Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation.

+ Proficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project).

+ Excellent interpersonal, communication, and organizational skills.

+ Lean Six Sigma or Agile certification preferred.

**Travel:** Occasional travel, domestic and international (up to 15%) may be required

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.