- Manage the product lifecycle of Quality Management System IT solutions and capabilities using Sparta TrackWise platform that support procceses, workflows and associated reports for Change Control, Product Complaint, Deviation, CAPA, Lab Investigation, Risks Mitigation Tracking, Audits, and Inspection Management.
- With Agile technical delivery expertise, collaborate with teams and squads of Platform Owner, Product Manager, Scrum Master, other Product Owners and stakeholders across development, IT, and Global Quality to deliver solutions that meet business needs, timeline and budget.
- Manage user stories and backlogs to drive value and outcome using Agile sprint delivery from user stories creation, product prototyping, development, optimizations and release management.
- As a Product Owner for QMS IT, work closely with Platform Owner, Product Manager, product teams, other partners and vendors to deliver product functionality using Sparta TrackWise platform that meets business needs.
- Manage requirements, epics and user stories gathering, documentation and prioritization with business stakeholders and product teams.
- Collaborate with process owners and SMEs to translate process needs to actionable business cases, capabilities, requirements, user stories, epics, specifications, development actions, testing and validation deliverables for TrackWise platform driving values and outcomes for Quality and compliance of Change Control, Product Complaint, Deviation, CAPA, Lab Investigation, Risk Mitigation Tracking, Audits, Inspection Management and more.
- Build, align and maintain prioritization of product backlogs, release plans and drive execution for QMS IT solutions and products with all relevant stakeholders and SMEs in alignment with business priorities and capabilities.
- Communicate, mitigate and manage resolutions for issues and risks impacting successful execution of release plan and sprint goals.
- Optimize the overall user experience by leading and driving opportunities for the performing service management.
- Use broad knowledge of IT, manage and take responsibility for sustainability of the end-to-end user experience of products developed, including but not limited to stakeholder management and status reports.
- Continually monitor and refine the product to maximize value that encompasses both technical and non-technical aspects. Contribute and influence directions on product vision, release features, roadmap and growth opportunities.
- Ensure delivered solutions are compliant with associated GxP regulations, Takeda Quality Management System (QMS) and Software Development Life Cycle standards, policies and procedures.
- Stay abreast with Agile/Scrum/SAFe best practices and emerging industry standards.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor Degree or equivalent in a scientific discipline, computer science or business administration.
- 4 years or more of relevant professional experience in IT service delivery, business analysis, product management, project management or related area.
- Professional in-depth knowledge of Agile process and principles.
- Excellent communication, presentation and leadership skills, business acumen and enterprise knowledge.
- Experience in design and implementing larger enterprise solutions or products.
- Ability to manage stakeholder relationship and drive continuous improvement across teams and projects.
- Ability to evaluate and recommend the right technology, solutions and capabilities to solve business problems.
- Understand design thinking and can explain and influence stakeholders.
- Experience working in a regulated software development environment.
- Experience in Pharmaceutical industry and/or Quality Management Systems domain.
- Experience working with virtual/agile team globally across different time zones and cultures.
- Experience with program management tools such as Atlassian, JIRA, Confluence.
- Familiarity with Sparta TrackWise system is a plus.
- Familiarity with data analytics and emerging digital capabilities is a plus.