Quality Management Specialist

4 weeks ago

Mumbai, Maharashtra, India vueverse. Full time

Job Summary:

We are seeking a highly experienced and motivated Subject Matter Expert (SME) for Veeva Vault QMS to lead the deployment and optimization of Quality Management System processes. The ideal candidate will bring deep domain expertise in QMS processes within the life sciences or pharmaceutical industry and will play a critical role in driving compliance, efficiency, and user adoption through effective system design and implementation.

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).

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