Quality Management Specialist (QMS Veeva Vault)

Job Summary

Subject Matter Expert (SME)

Key Responsibilities

• Serve as the

  SME for Veeva Vault QMS

  , leading deployment, configuration, and optimization efforts.
• Understand existing QMS processes and workflows; identify gaps, inefficiencies, and areas for improvement.
• Work closely with stakeholders, business users, and functional SMEs to gather and analyze requirements
• Design, implement, and refine QMS processes and workflows that are user-friendly and

  aligned with global regulatory requirements

  (e.g., 21 CFR Part 11, GxP, ISO standards).
• Support validation and testing of QMS functionalities and ensure documentation aligns with compliance standards.
• Provide training, knowledge transfer, and ongoing support to business and technical teams.
• Collaborate cross-functionally with IT, Quality Assurance, Regulatory, and Compliance teams.
• Act as a liaison between business and technical teams to ensure seamless integration and solution delivery

Required Skills & Experience

• Minimum 8

  years of experience

  in QMS domain within pharma/biotech/life sciences.
• Proven experience leading or acting as an SME for

  Veeva Vault QMS deployment

  .
• Deep understanding of

  Quality Management processes

  (e.g., CAPA, Change Control, Audit Management, Deviations).
• Strong knowledge of

  industry regulations and compliance frameworks

  (GxP, 21 CFR Part 11, ISO).
• Excellent communication, stakeholder engagement, and problem-solving skills.
• Experience in driving process design and change management initiatives.

Preferred Qualifications

• Veeva Vault QMS certification (if available).
• Background in Quality Assurance or Regulatory Operations.
• Experience working in global delivery models (onsite-offshore collaboration).