Veeva Vault EQMS Specialist
Scorpion Therapeutics, Rancho Santa Fe, CA, United States
Responsibilities:
Lead or support end-to-end implementation of
Veeva Vault Quality Suite , including requirements gathering, configuration, testing, validation, and go-live activities.
Translate business needs into functional specifications and system design within Veeva Vault.
Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles.
Conduct detailed process mapping of current-state and future-state EQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training).
Facilitate workshops with cross-functional stakeholders to define requirements and align system capabilities with business objectives.
Identify opportunities for process improvements and automation within Veeva.
Support or lead system validation activities including user requirements (URS), functional specifications, IQ/OQ/PQ, and change control in compliance with GxP and 21 CFR Part 11.
Ensure adherence to internal quality standards, regulatory expectations, and IT/CSV methodologies.
Testing & Deployment
Develop and execute test scripts, manage defects, and facilitate UAT sessions.
Support go-live planning, cutover activities, and hypercare.
Maintain updates to Veeva releases, including impact assessments and regression testing.
Training & Support
Develop user training materials and deliver hands-on training for business end users.
Provide ongoing support, troubleshoot issues, and manage enhancement requests.
Serve as a subject matter expert (SME) for Veeva Vault within the Quality organization.
Requirements:
3+ years of experience as a Business Analyst in Life Sciences Quality (Pharma, Biotech, or Medical Devices).
Hands-on experience with full Veeva Vault implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training).
Strong working knowledge of GxP, 21 CFR Part 11, Annex 11, and core quality system processes.
Experience with computer system validation (CSV) and creation of validation documentation.
Excellent communication skills with the ability to translate technical concepts for non-technical audiences.
Strong analytical, problem‑solving, and stakeholder management capabilities.
Must be able to work
on site
Monday to Friday.
Preferred Qualifications:
Veeva Vault Administrator or Vault Quality certification.
Experience working with global teams and regulated environments.
Familiarity with integration tools, APIs, and downstream/upstream system interfaces.
Experience in managing enhancements post-implementation and supporting continuous improvement.
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Lead or support end-to-end implementation of
Veeva Vault Quality Suite , including requirements gathering, configuration, testing, validation, and go-live activities.
Translate business needs into functional specifications and system design within Veeva Vault.
Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles.
Conduct detailed process mapping of current-state and future-state EQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training).
Facilitate workshops with cross-functional stakeholders to define requirements and align system capabilities with business objectives.
Identify opportunities for process improvements and automation within Veeva.
Support or lead system validation activities including user requirements (URS), functional specifications, IQ/OQ/PQ, and change control in compliance with GxP and 21 CFR Part 11.
Ensure adherence to internal quality standards, regulatory expectations, and IT/CSV methodologies.
Testing & Deployment
Develop and execute test scripts, manage defects, and facilitate UAT sessions.
Support go-live planning, cutover activities, and hypercare.
Maintain updates to Veeva releases, including impact assessments and regression testing.
Training & Support
Develop user training materials and deliver hands-on training for business end users.
Provide ongoing support, troubleshoot issues, and manage enhancement requests.
Serve as a subject matter expert (SME) for Veeva Vault within the Quality organization.
Requirements:
3+ years of experience as a Business Analyst in Life Sciences Quality (Pharma, Biotech, or Medical Devices).
Hands-on experience with full Veeva Vault implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training).
Strong working knowledge of GxP, 21 CFR Part 11, Annex 11, and core quality system processes.
Experience with computer system validation (CSV) and creation of validation documentation.
Excellent communication skills with the ability to translate technical concepts for non-technical audiences.
Strong analytical, problem‑solving, and stakeholder management capabilities.
Must be able to work
on site
Monday to Friday.
Preferred Qualifications:
Veeva Vault Administrator or Vault Quality certification.
Experience working with global teams and regulated environments.
Familiarity with integration tools, APIs, and downstream/upstream system interfaces.
Experience in managing enhancements post-implementation and supporting continuous improvement.
#J-18808-Ljbffr