Role Description

The Veeva Vault System Senior Specialist is responsible for administering and driving the Global Veeva administration related to Documents, Training and Quality Management System modules. This role ensures the system operates efficiently, securely and in compliance with regulatory requirements and internal policies while fostering a culture of quality, risk management, and continuous improvement.

Schedule: 6:00 PM – 2:00 AM EST

Responsibilities:

• System Administration & Configuration:
  • Support routine Veeva Vault administration activities, including user account maintenance, role assignments, group membership updates, and access request processing in accordance with approved procedures.
  • Assist with configuration updates for document types, metadata, workflows, lifecycle states, templates, controlled vocabularies, user roles, and permissions under the direction of senior administrators or system owners.
  • Provide first-line user support for Veeva Vault Quality applications by triaging issues, answering basic system questions, documenting incidents, and escalating complex items as appropriate.
  • Support document lifecycle activities such as controlled document routing, workflow troubleshooting, version control, issuance support, archival assistance, and metadata/data quality checks.
  • Create or update work instructions, quick reference guides, training materials, job aids, and support communications for end users.
  • Assist with reports, dashboards, metrics, and data extracts to support business monitoring, compliance reviews, and operational decision-making.
  • Participate in change control activities by documenting requirements, supporting testing, coordinating approvals and ensuring updates are implemented in a controlled manner.
  • Collaborate with Quality, IT, Validation, Training, Document Control, and business SMEs to support continuous improvement of Veeva Vault processes and user experience.
• Business Process Support:
  • Collaborate with cross-functional teams to understand requirements and translate them into system solutions.
  • Support quality processes such as Change Control, CAPA, Deviations, Complaints, and Document Management.
  • Ensure alignment with GMP and other regulatory requirements.
• Global Governance & Standards:
  • Establish and maintain global Templates for SOPs, Forms, Documentation Management, and all Quality System Modules.
  • Lead or participate in cross-functional governance forums, quality councils, and harmonization initiatives.
• System Maintenance & Upgrades:
  • Assist with Veeva Vault release management activities, including impact assessment support, test script preparation, regression testing, defect documentation, and deployment readiness tasks.
  • Support validation and compliance deliverables, including drafting test cases, test execution, evidence capture, deviation/defect documentation, traceability support, and maintenance of system documentation.
  • Maintain documentation for system configuration and validation activities.
• Collaboration & Stakeholder Engagement:
  • Work closely with site QA, Validation, Engineering, Automation, and IT teams to ensure alignment and consistent execution of quality programs.
  • Collaborate with Quality, HR, IT, and business stakeholders to support onboarding and ongoing training.
• Data & Security Management:
  • Ensure data integrity, backup, and disaster recovery protocols are in place.
  • Monitor system logs and security alerts; implement corrective actions as needed.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field preferred but not required.
• Bachelors + 5 years or Masters + 3 years of experience in the pharmaceutical or biotechnology industry.
• Minimum 2 years of experience in Quality Systems, Document Control, IT systems support, regulated operations, validation support, or life sciences business systems.
• Basic understanding of GxP, data integrity, document control, training, change control, or QMS processes preferred.
• Strong attention to detail and ability to follow controlled procedures in a regulated environment.
• Ability to document issues clearly, capture objective evidence, and communicate status to stakeholders.
• Proficiency with Microsoft Office applications, especially Excel, Word, PowerPoint, Teams, and Outlook.
• Ability to work independently and in a global, cross-functional team environment.
• Certified system administrator with Veeva or equivalent.

Requirements

• Must be able to work 6 PM – 2 AM EST.

Benefits

• Medical, Dental, & Vision.
• Health Savings Accounts.
• Flexible Spending Accounts.
• Disability Benefits.
• Life Insurance.
• Voluntary Benefits.
• Paid Absences.
• 401k Benefits.

Company Description

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.