Veeva Quality Lead, GxP & Vault QMS Consultant
Overview
You will lead GxP quality transformations for life sciences clients, owning the design and rollout of Veeva Vault QMS solutions across R&D, manufacturing, clinical, and lab functions. You will serve as the senior SME for quality process architecture, bridging regulatory expectations with scalable system implementations. Collaborating with cross-functional teams, you will shape quality strategies for sponsors and ensure compliance with GxP standards. This role puts you at the center of digital quality innovation, with direct impact on client outcomes and team growth.
What You'll Do8
- 1Design end-to-end Vault QMS solutions covering change control, deviations, CAPA, and audit management for life sciences clients.
- 2Drive document control and training compliance workflows within Veeva Vault, ensuring alignment with GxP regulations.
- 3Advise sponsors on supplier qualification and quality system design, integrating Veeva best practices across the value chain.
- 4Lead client workshops to map quality processes and define Vault configuration requirements.
- 5Configure Veeva Vault QMS modules for CAPA, Audit, and Training to meet regulatory expectations.
- 6Coach internal teams on Veeva capabilities and GxP compliance standards, raising overall delivery quality.
- 7Own the quality roadmap for multiple projects, coordinating with stakeholders to prioritize and execute changes.
- 8Develop and deliver Vault training materials, enabling clients to manage quality processes independently.
Requirements7
- 15+ years in life sciences quality roles, with deep expertise in GxP processes and Veeva Vault QMS.
- 2Proven track record implementing Vault QMS for change control, deviations, CAPA, and audit management.
- 3Strong knowledge of FDA and EU regulations for pharmaceuticals and medical devices.
- 4Experience advising sponsors on quality system design and Veeva configuration.
- 5Certification in Veeva Vault QMS (e.g., Veeva Certified Consultant) is a plus.
- 6Excellent communication skills for leading client workshops and cross-functional collaboration.
- 7Ability to travel to client sites in New York and surrounding areas as needed.
Salary Insight
$125 - $146k per year
Location
Required Skills
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