QMS Lead Role

3 weeks ago

Foster City, United States Omni Inclusive Full time

Must Have's:
Exposure to Technologies
1. Veeva Vault Administration
2. Veeva QualitDocs
3. Veeva QMS

Domain/Process
1. Quality
2. Medical Devices, Customer & service excellence
3. Knowledge in Life science domain and GxP principles.

Responsibilities:
Perform onsite QMS lead role and work with business team and program team in managing the deliverables as per Gilead Releases.
• Participates in developing functional requirements, design, testing, training, and implementation of Veeva Vault Quality docs and QMS.
• Experience in Veeva Vault Quality Docs and Veeva Vault QMS configuration is required.
• Ability to perform Consultant role as per GVault Requirements.
• Work closely with Business team in resolving the technical gaps identified during the feature life cycle.
• Design architecture based on process requirements, application and system landscape.
• Design architecture based on process requirements, application and system landscape.
• Work on high level design and coordinate with Offshore Tech Lead and finalize the design.
• Work with Offshore Tech Lead on review of iteration deliverables.
• Walkthrough / POC / Demo with Business - Contribute and participate in Release checkpoint meetings.
• Consulted for deep understanding on resolving/providing solutions for P1 tickets.
• Experience in integrations
• Responsible for expanding user stories with requirements/ Use Cases in Azure Boards.
• Responsible for managing requirements and design discussions in the user stories in Azure Boards.
• Good Stakeholder management and client communication.
• Be able to juggle multiple priorities in a high visibility, compliance related environment.

Relevant Role Expectations
• Experience working at a Life Sciences client.
• Worked as a Business Analyst is an added advantage.
• Excellent verbal and written communication skills with the ability to communicate information clearly and concisely to customers.
• Proven ability to work remotely and independently in support of clients.

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