Moderna

Sr. GxP Product Manager

Cambridge, Massachusetts, USA · Senior · Contract

Sponsorship not specified$146k-$234kDetected 28 days ago

Data VisualizationProduct ManagementAgileJiraConfluenceExcelCollaborationTime ManagementPublic SpeakingMicrosoft OfficeGxP

About the role

At Moderna, we are revolutionizing modern healthcare by leveraging the power of digital technology to maximize our impact on patients' lives.
By joining us, you will have the unique opportunity to contribute to an organization making an unprecedented difference in society.
You will bring deep product expertise in Laboratory Information Management Systems (LIMS), E2E data pipeline solutions, GxP reporting/data visualizations and GxP-compliant environments.

Responsibilities

As a Senior GxP Product Manager, Digital, you will lead system engineering initiatives and manage multiple digital platforms and applications that align with Moderna's clinical and regulatory digital roadmap.
Your role will be to ensure that these systems operate efficiently, reliably, and compliantly while remaining scalable to support our diverse portfolio.
You will collaborate closely with teams across regulatory operations, clinical, and other business units to maximize the value of our digital platforms.
Lead backlog refinement sessions, manage sprint planning in collaboration with delivery teams, define and prioritize product features and scope against Definition of Ready ("DoR") standards and clear acceptance criteria
Translate complex technical requirements to drive alignment and decision-making, inclusive of data dependencies, into clear and business-friendly narratives through writing, verbal presentations, slides, or a combination thereof.
Contribute to business case development and ROI impact to drive measurable value
Manage vendor partners in a regulated environment to ensure compliance and operational effectiveness.
Prioritize, organize, and manage platform operations, including tracking operational metrics and generating reports.
Oversee application lifecycle and release management activities, ensuring product configurations efficiently maintain compliance and that all systems meet GxP requirements including 21 CFR Part 11, Annex 11, and ALCOA+ principles.
Lead and/or contribute to impact assessments, evaluating how process changes affect system behavior/requirements and articulating key outcomes back to business stakeholders

Nice to have

A highly-organized, data-driven systems thinker who understands the interdependencies between multiple platforms, diverse processes, cross-functional teams and how these impact enterprise data strategies and outputs
You know when to dive into the deep details and when to pull back to provide a high-level view
You speak these languages well and can effortlessly translate between them based on your audience: business, product, technical and data
Excellent time management skills and ability to swap between multiple hats in a fast-paced environment.
You love having many hats…and know which one to wear when
Savings and investment opportunities to help you plan for the future

Skills

JIRA for backlog management, refinement and sprint planning
Confluence for version-controlled functional requirements and other key product documentation
Validation documentation and SDLC processes
Strong proficiency in the following tools and areas
Excel, PowerPoint, Kneat

Compensation

The salary range for this role is $145,900.00 - $234,200.00.

Visa & Work Authorization

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This listing is sourced directly from Moderna's careers page and normalized into a canonical job model.