Veeva QMS Consultant

Job Description:

Veeva QMS consultant to support the implementation, optimization, and ongoing management of Quality Management Systems (QMS) within a regulated scientific environment. This role will focus on leveraging Veeva Vault QMS solutions to ensure compliance, streamline processes, and enhance operational efficiency across quality and regulatory functions. The ideal candidate combines strong scientific domain knowledge with technical expertise in QMS platforms and Veeva Vault applications.

Responsibilities:

• Lead the implementation, configuration, and support of QMS applications, with a focus on Veeva Vault QMS
• Collaborate with cross-functional stakeholders (Quality, Regulatory, R&D, IT) to gather requirements and translate them into system solutions
• Ensure compliance with industry regulations (e.g., GxP, FDA, ISO standards) through proper system design and usage
• Provide subject matter expertise on QMS processes including CAPA, Change Control, Deviations, Audits, and Document Management
• Configure and maintain Veeva Vault modules to support business processes and regulatory requirements
• Conduct system validation activities, including documentation, testing, and change control
• Support data migration, system upgrades, and integrations with other enterprise systems
• Deliver end-user training and provide ongoing support to ensure effective system adoption
• Identify opportunities for process improvement and system optimization
• Participate in audits and inspections, providing system-related support and documentation

Requirements:

• QMS Certification (e.g., ASQ, ISO-related certifications, or equivalent)
• Veeva Certification, specifically related to Veeva Vault (QMS preferred)
• Proven experience working with Quality Management Systems (QMS) in regulated environments
• Hands-on experience with Veeva Vault QMS, including configuration and administration
• Strong understanding of GxP compliance requirements and validation processes (CSV/CSA)
• Experience with quality processes such as CAPA, Change Control, Deviations, and Audits
• Excellent analytical, problem-solving, and communication skills

Qualifications:

• Bachelor or Master''''''''s degree in Life sciences or Computer Sciences
• 5+ years'''''''' experience with Computer Systems Validation is required for this role
• Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11, 210, 211, EU Annex 11, 15 requirements
• QMS Certification (e.g., ASQ, ISO-related certifications, or equivalent)
• Veeva Certification, specifically related to Veeva Vault (QMS preferred)
• Proven experience working with Quality Management Systems (QMS) in regulated environments
• Hands-on experience with Veeva Vault QMS, including configuration and administration
• Strong understanding of GxP compliance requirements and validation processes (CSV/CSA)
• Experience with quality processes such as CAPA, Change Control, Deviations, and Audits
• Excellent analytical, problem-solving, and communication skills