This role is positioned within the Veeva Quality Platform Team, responsible for contributing to the solution design, implementation, and continuous improvement of the Veeva QMS with specific alignment to the Quality business processes.
The Veeva QMS Business Analyst will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability.
- Applies a structured approach to discover, document, and manage business process, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements.
- Gathers insight into user journey, behavior, motivation, and pain points. Exposes unarticulated problems and unmet needs.
- Documents business process, business, and user needs in the form of problem statements to make up the backlog. Facilitates the “how” with the Development team.
- Gains expertise in the business area
- Manage business analysis for Vault Quality per agreed priority backlog items in JIRA.
- Participate in impact assessment activities, reviewing proposed changes and ensuring impact understood across QMS.
- Deliver product enhancements through agreed backlog process to ensure Veeva Vault Quality evolves to meet business needs
- Ensure Quality Vault remains compliant as a Validated Solution through verification testing, documentation, and validation efforts
- Collaborate across the Manufacturing IT & R&D IT Quality teams and work closely with Product Manager and Veeva Platform Lead, IT Architects, and Value/Product Line teams
- Collaborate with Veeva Enterprise Managed Services on product features
- Minimum Level of Education Required - Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background on how Information Technology supports the delivery of business objectives
- Preferred Level of Education - Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.
- Minimum Level of Job-Related Experience Required - 3+ year of Veeva Vault Quality experience. Veeva QMS is a Validated SAAS application, and therefore documented certification and experience of working in a GxP environment is required.
Preferred Experience and Skills:
- Experience in IT, Quality and relevant business areas
- Understanding of Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management)
- Experience in solution delivery with GMP systems
- Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes
- Experience in an Agile environment
What we need from you to be successful in this role:
- Strong communication skills. Strong business acumen, and easy rapport with peers and executives
- Problem solving skills are required to solve business process issues identified in the backlog. Be capable to resolve potential conflicts between differing user requirements.
- Written and verbal communication skills including the ability to communicate with both a business and a technical audience.
- The ability to work independently and effectively as a team across global hubs, and maintain a highly collaborative, transparent effort.
- Demonstrated ability to solve problems with a sense of ownership, enthusiasm, and innovation
- Ability to work in a global, multi-cultural, English-speaking environment
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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