Manager, Quality – Digital Systems
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Job Description
Manager administering Pfizer’s Veeva eQMS for Regulatory Quality Assurance. Driving system governance, reporting, process improvement, and AI-enabled transformation in pharmaceutical quality operations.
Responsibilities:
- Serve as the primary business administrator for Veeva eQMS on behalf of Regulatory Quality Assurance
- Triage and resolve business administration requests, partnering with technical teams on complex issues
- Own access request intake and provisioning across RQA’s digital systems environments
- Support Veeva release coordination through UAT, business approvals, communications, and production deployments
- Maintain and improve job aids, quick reference guides, and user-facing documentation
- Develop, prepare, and deliver reporting across functional areas
- Provide guidance on Veeva Vault configuration options, object relationships, shared configuration dependencies, and downstream impacts of changes
- Support eQMS enhancement request triage and impact assessment
- Stay current on Veeva developments, GxP digital systems best practices, AI technologies, and regulatory expectations
- Participate in eQMS governance forums representing RQA Digital Systems
- Represent the RQA Digital Systems team in enterprise programs, scope responsibilities, develop execution plans, and deliver against them
- Maintain ownership of workstream status and decisions; surface blockers and escalation points
- Coordinate with Pfizer Digital and cross-functional teams on quality data integrity and system continuity
- Issue stakeholder communications and prepare leadership briefing materials
- Execute periodic data extracts, basic dashboarding, and data queries supporting regulatory and quality operations
- Identify process improvement and digital transformation opportunities
- Evaluate AI use cases, partner with technical teams, and drive adoption of AI-enabled solutions
- Support AI integration into quality workflows, eQMS process redesign, and platform evolution
Requirements:
- Bachelor’s degree in Life Sciences, Information Systems, Computer Science or a related field with 5+ years of relevant industry experience
- Excellent written and verbal communication skills; able to produce clear documentation, user-facing guidance, and stakeholder-ready reports
- Demonstrated experience working directly and iteratively with business stakeholders to understand their underlying needs and workflows
- Working knowledge of Veeva Vault eQMS or a comparable enterprise quality/GxP system, including working knowledge of vault object relationships and configuration dependencies
- Demonstrated, hands-on curiosity about AI-enabled tools, automation, or advanced analytics, with concrete examples of applying them to improve processes and drive innovation
- Experience in a GxP-regulated pharmaceutical or biotech environment with demonstrated understanding of quality management system processes
- Proven ability to operate autonomously and collaboratively on complex, cross-functional work
- Strong analytical and problem-solving skills; able to assess the downstream impact of system changes and translate business needs into actionable decisions
- Basic coding, scripting, and/or dashboarding experience (e.g., SQL, Power BI, Spotfire, or similar) preferred
- Background as a Veeva Vault business administrator, business analyst, or similar business-technology liaison role preferred
- Experience with Veeva Vault configuration in a pharma or CRO setting, including participation in system releases, eQMS governance forums, or enhancement request management preferred
- Familiarity with Pfizer enterprise data and/or source systems preferred
- Exposure to data platforms such as Snowflake and DSS/Dataiku or related data engineering tools preferred
- Working knowledge of Microsoft Power Automate or similar automation tools preferred
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