Manager, Quality – Digital Systems

This is a fully remote position, open to applicants in India.

📋 Description

• Act as the main business administrator for Veeva eQMS representing Regulatory Quality Assurance.

• Assess and resolve business administration inquiries, collaborating with technical teams on intricate issues.

• Manage access request submissions and provisioning across RQA’s digital systems environments.

• Assist in coordinating Veeva releases through User Acceptance Testing (UAT), business approvals, communications, and production rollouts.

• Update and enhance job aids, quick reference guides, and documentation for users.

• Create, prepare, and present reports across various functional areas.

• Provide advice on Veeva Vault configuration options, object relationships, shared configuration dependencies, and the downstream effects of modifications.

• Support the triage and impact assessment of eQMS enhancement requests.

• Keep abreast of developments in Veeva, best practices for GxP digital systems, AI technologies, and regulatory standards.

• Participate in eQMS governance forums as a representative of RQA Digital Systems.

• Represent the RQA Digital Systems team in enterprise initiatives, define responsibilities, create execution plans, and ensure their delivery.

• Maintain oversight of workstream status and decisions; identify blockers and escalation points.

• Collaborate with Pfizer Digital and cross-functional teams on quality data integrity and system continuity.

• Issue communications to stakeholders and prepare briefing materials for leadership.

• Conduct periodic data extractions, basic dashboarding, and data queries to support regulatory and quality operations.

• Identify opportunities for process improvement and digital transformation.

• Evaluate AI use cases, collaborate with technical teams, and promote the adoption of AI-enabled solutions.

• Assist in integrating AI into quality workflows, redesigning eQMS processes, and evolving the platform.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or a related discipline, along with 5+ years of pertinent industry experience.

• Exceptional written and verbal communication skills; capable of producing clear documentation, user guidance, and stakeholder-ready reports.

• Proven experience working directly and iteratively with business stakeholders to comprehend their fundamental needs and workflows.

• Working knowledge of Veeva Vault eQMS or a similar enterprise quality/GxP system, including understanding vault object relationships and configuration dependencies.

• Demonstrated curiosity about AI-enabled tools, automation, or advanced analytics, with specific examples of applying them to enhance processes and foster innovation.

• Experience in a GxP-regulated pharmaceutical or biotech setting, with a solid understanding of quality management system processes.

• Proven ability to work independently and collaboratively on complex, cross-functional projects.

• Strong analytical and problem-solving abilities; capable of assessing the downstream impact of system changes and translating business needs into actionable decisions.

• Preferably possesses basic coding, scripting, and/or dashboarding experience (e.g., SQL, Power BI, Spotfire, or similar).

• Background as a Veeva Vault business administrator, business analyst, or in a related business-technology liaison role is preferred.

• Experience with Veeva Vault configuration in a pharmaceutical or CRO environment, including participation in system releases, eQMS governance forums, or enhancement request management is preferred.

• Familiarity with Pfizer enterprise data and/or source systems is preferred.

• Exposure to data platforms such as Snowflake and DSS/Dataiku or related data engineering tools is preferred.

• Working knowledge of Microsoft Power Automate or similar automation tools is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and flexible work arrangements.

• Opportunities for professional development and continuous learning.

• Engaging work environment with a focus on teamwork and innovation.