GxP Product Manager

Moderna•Cambridge, MA

About The Position

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.

Requirements

The ideal candidate will have strong GxP Business Analyst skills and experience who made a successful transition to a Product Management role.
Minimum 7+ years experience in GxP biotech/pharma space
Minimum of 5+ years as a Product Owner/Product Manager in digital healthcare/biotech/pharma space with strong experience in delivering E2E data solutions and GxP reporting outcomes. Spotfire and Tableau experience highly desired.
Minimum of 5+ years as GxP Business Analyst specializing in LIMS systems in biotech or pharma space. Labvantage 8.7 experience highly desired.
Minimum of 3+ years of hands-on experience with GxP LIMS systems
Strong experience in data lifecycles and data governance procedures
Strong understanding of stability testing procedures, data and regulatory requirements to maintain stability testing compliance
Expert in following tools and areas: 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

Nice To Haves

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
Team player who is unafraid to ask the hard “what-if” questions (in the appropriate tone and forums) to probe on symptoms in order to get to the actual problem statement/root cause of what we are solving for
You understand the criticality of a strong user experience to drive launch and adoption
Excellent communicator with strong active listening skills and storytelling abilities, an empathetic approach and ability to rapidly align clear scope across diverse cross-functional global team processes
Strong collaboration and relationship-building skills with a diverse set of business stakeholders and technical delivery teams
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
Ability to manage conflicting priorities and thrive in a fast-paced, dynamic environment with shifting priorities.
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

Responsibilities

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 with globally distributed teams, including offshore delivery teams
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.
Contribute to the creation of short- and long-term roadmaps that deliver value, drive efficiencies, and support Moderna’s bold digital vision.
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.

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

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