Veeva Vault QMS Lead (Hybrid - PA or NJ)

Job Description

Position Description:

Veeva Vault QMS Lead

This role is positioned within the Veeva Vault Quality Platform Team, responsible for contributing to the technical solution design, implementation and continuous improvement of the Veeva Quality Suite. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

Key Responsibilities:

• Provide Product expertise in Veeva Quality suite as a certified Vault platform administrator and Quality Management System (QMS) system administrator and configuration specialist.

• Primary point of contact for the Veeva Vault QMS platform, owning the QMS platform roadmap and backlog

• Collaborate with stakeholders across Quality, Compliance, IT Architecture teams to prioritize requirements, ensuring alignment with business

• Act as a scrum master for releases within the VQMS portfolio.

• Manage advanced configuration changes for Vault Quality per agreed priority backlog items in JIRA.

• Participate in impact assessment activities, reviewing proposed changes and ensuring impact understood across QMS and QualityDocs.

• Deliver product enhancements through agreed backlog process to ensure Veeva Vault Quality evolves to meet business needs

• Coach and provide subject matter expertise to fellow team members.,

• Ensure Quality Vault remains compliant as a Validated Solution through verification testing, documentation, and validation efforts

• Collaborate across the Manufacturing & R&D IT Quality teams and work closely with Product Teams ,Veeva Platform Lead, IT Architects, and Value/Product Line teams

• Collaborate with Veeva Enterprise Managed Services on product features

• Collaborate with Application Management Services team for end user support and system operations.

• Manage and maintain meta data in Quality Vault

• String communication skills

Position Qualifications:

Education Minimum Requirement:

• 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.

• Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.

Required Experience and Skills:

• 4+ year of Veeva Vault Quality experience and particularly desirable is QMS experience.

• Veeva Quality Docs and QMS is a Validated SAAS application, and therefore documented certification and experience of working in a GxP environment is required.

• Problem solving skills are required to solve business process issues identified in the backlog.

• Additionally, the candidate may identify problems with the product and should be sufficiently skilled to confidently propose solutions to the Product Manager and if required work with the Vendor.

• The candidate must not only understand the current configuration, but also look to best practices to best solve any new enhancements without impact on any other workflows that may share objects.

• 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

Preferred Experience and Skills:

• Experience in IT Quality and relevant business areas

• Excellent communication, collaboration and stakeholder management skills with the ability to interact effectively with cross-functional teams .

• Understanding of Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management)

• As knowledge of Veeva Quality Suite grows, more advanced configuration work is expected. This knowledge will be used on a daily basis as part of configuration work, handling changes requests and will ultimately support business processes across Manufacturing and R&D.

• Experience in solution delivery with GMP systems

• Experience with architecture, integration, interfaces, portals, and/or analytics

• Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) proc