Veeva Vault System Senior Specialist (Night Shift: 6 PM - 2 AM EST)

Schedule

• 6:00 PM – 2:00 AM EST

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• Ensure data integrity, backup, and disaster recovery protocols are in place.
• Monitor system logs and security alerts; implement corrective actions as needed.

Requirements

• Must be able to work 6 PM – 2 AM EST
• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmacy, or related field preferred 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