GxP Product Manager

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. 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. This dynamic role blends the Product Manager role with GxP Business Analyst skillsets and is key to delivering validated, compliant, and impactful lab informatics solutions which drive user adoption, ongoing business value and responds to the ongoing needs of our users around the world. 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. You will bring deep product expertise in Laboratory Information Management Systems (LIMS), E2E data pipeline solutions, GxP reporting/data visualizations and GxP-compliant environments. As the day-to-day product manager on this high-visibility initiative, your role will require management of multiple workstreams, including but not limited to UX, architecture, configuration, integration, and system validation. You will collaborate closely with business stakeholders and users across Analytical Development, Quality, QA and business operations to align process and functions as well as our engineering and validation teams to implement technical solutions which align with our overarching digital strategy, while ensuring a strong user experience which is compliant and maintains operational excellence. Here's What You’ll Do Defining user stories, clear acceptance criteria and precise functional scope for agreed upon features which capture business requirements and expected outcomes Serve as a liaison between technical teams and business users to ensure mutual understanding and shared expectations by partnering with stakeholders and teams to elicit and document detailed business, functional, and data requirements in collaboration with end users Alignment on what defines success and how we will measure success post-launch with clear KPI’s Ruthless and continual prioritization of the backlog and sprint work items based on time, definition of ready (“DoR”) criteria, resources and business value Act as the go-to expert for product capabilities, integrations, and compliance impacts. 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 Ensuring successful delivery through adaptive agile product management practices which align to GxP standards which meet Definition of Done (“DoD”) criteria and GxP business analyst expertise 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. Alignment with business stakeholders on data governance and operational process needs Lead and/or contribute to impact assessments, evaluating how process changes affect system behavior/requirements and articulating key outcomes back to business stakeholders Key contributor to Computer System Validation (CSV) efforts, including authoring or reviewing validation documentation (URS, FRS, IQ/OQ/PQ, test protocols). Contribute to business case development and ROI impact to drive measurable value Competency in measuring and reporting on product and project status to a variety of audiences, including stakeholders and senior leadership. Experience working ... (truncated, view full listing at source)