Sr. GxP Product Manager

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. 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.

Responsibilities

• Define 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
• Align on what defines success and how we will measure success post-launch with clear KPIs
• Ruthlessly and continually prioritize the backlog and sprint work items based on time, definition of ready (“DoR”) criteria, resources and business value
• 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
• Ensure 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
• Align with business stakeholders on data governance and operational process needs
• Contribute to impact assessments, evaluating how process changes affect system behavior/requirements and articulating key outcomes back to business stakeholders
• Lead and/or contribute 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
• Measure and report on product and project status to a variety of audiences, including stakeholders and senior leadership
• 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

Requirements

• 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
• 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

Qualifications

• Strong GxP Business Analyst skills and experience who made a successful transition to a Product Management role
• 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
• 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

Skills

• 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
• 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
• Understand the criticality of a strong user experience to drive launch and adoption
• Speak these languages well and can effortlessly translate between them based on your audience: business, product, technical and data
• 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

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
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

Pay & Benefits

The salary range for this role is $145,900.00 - $234,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.