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Pfizer

Manager, Quality - Digital Systems

Posted 5 Hours Ago
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In-Office or Remote
Hiring Remotely in Chennai, Tamil Nadu
Senior level
In-Office or Remote
Hiring Remotely in Chennai, Tamil Nadu
Senior level
Lead administration and continuous improvement of Veeva eQMS for Regulatory Quality Assurance. Own access management, release coordination, reporting, and user documentation. Provide Vault configuration expertise, triage enhancement requests, represent Digital Systems in cross-functional programs, support data extracts and reporting, and drive AI-enabled process improvements and platform transformation within a GxP-regulated pharmaceutical environment.
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Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.
What You Will Achieve
The Manager, Quality - Digital Systems will serve as a subject matter expert for RQA's digital quality systems, with experience in Veeva eQMS configuration and GxP-regulated system operations. This role is accountable for the reliable administration and continuous improvement of Veeva eQMS processes, including access management, business administration, release coordination, and reporting. The successful candidate will bring configuration expertise - understanding vault object relationships, shared versus instance-specific configuration, and the downstream consequences of proposed system changes - enabling faster, better-informed decisions on enhancement requests and system design questions. The successful candidate must understand stakeholder needs, assess business and technical trade-offs, and support technology decisions that advance quality operations and broader business objectives.
Beyond day-to-day operations, this role independently represents the RQA Digital Systems team within cross-functional programs and enterprise initiatives. This includes scoping RQA's responsibilities within a given program and developing and driving the execution plan on behalf of the team. This role operates with a high degree of autonomy, maintaining clear situational awareness across assigned responsibilities and bringing issues and decisions forward proactively.
This position requires deep Veeva domain knowledge, strong analytical and organizational skills, and the ability to operate effectively in a regulated pharmaceutical environment, both as a technical advisor and as an accountable owner of complex, cross-functional work.
Responsibilities:
Veeva eQMS Operations & Administration
  • Serve as the primary business administrator for Veeva eQMS on behalf of Regulatory Quality Assurance.
  • Manage and resolve system administration tickets requiring business-level intervention; triage and escalate as appropriate.
  • Own access request intake and provisioning across RQA's digital systems environments
  • Support Veeva release coordination through UAT, business approvals and communications, and production deployments.
  • Maintain and continuously improve job aids, quick reference guides, and user-facing documentation for Veeva eQMS and integrated supporting tools, keeping materials current across system releases.
  • Develop, prepare, and deliver reporting across functional areas.

eQMS Systems Expertise & Advisory
  • Provide authoritative guidance on Veeva vault configuration options in support of the businesses needs, including object relationships, shared configuration dependencies, and the downstream impact of proposed changes.
  • Support the triage and formulation of eQMS enhancement requests, providing technical context and impact assessment alongside stakeholder needs and operational impacts to inform prioritization and decision-making.
  • Stay current on Veeva platform developments and GxP digital systems best practices, especially with respect to emerging AI technologies, applying that knowledge to improve system design and operational outcomes.
  • Participate in eQMS governance forums, representing RQA Digital Systems' interests and staying current on platform developments.

Cross-Functional Program Support
  • Independently represent the RQA Digital Systems team within enterprise programs and initiatives requiring digital systems support, scoping team responsibilities, developing execution plans, and delivering against them.
  • Maintain clear ownership of workstream status and decisions; proactively surface blockers or escalation points to leadership.
  • Coordinate with Pfizer Digital and cross-functional teams to support enterprise quality data integrity and system continuity efforts.

Reporting & Data Operations
  • Issue clear and timely communications, ensuring stakeholders are informed and aligned on timelines and expected outcomes
  • Execute periodic data extracts and reporting tasks in support of regulatory and quality operations, ensuring accuracy, timeliness, and appropriate documentation.
  • Develop and maintain operational documentation and user guidance for current and legacy quality systems to ensure operational continuity.
  • Gather, synthesize, and prepare materials for stakeholder communications and leadership briefings, translating system and data insights into accessible formats.

Transformation & Continuous Improvement
  • Proactively identify opportunities for meaningful process improvement and digital transformation within RQA's quality systems operations, bringing both technical grounding and operational context to proposed solutions.
  • Apply practical AI knowledge to evaluate use cases, partner with technical teams, and support adoption of AI-enabled solutions.
  • Contribute to and support broader organizational transformation initiatives, including AI integration into quality workflows, eQMS process redesign, and platform evolution.
  • Stay current on Veeva platform capabilities, GxP digital systems trends, and regulatory expectations, applying emerging best practices to improve the team's operations and delivery.

QUALIFICATIONS
Required:
  • Bachelor's degree in Life Sciences, Information Systems, Computer Science, or a related field with 5+ years of relevant industry experience; advanced degree preferred.
  • Hands-on Veeva Vault eQMS experience, including configuration, administration, and working knowledge of vault object relationships and shared configuration dependencies.
  • Demonstrated knowledge of AI-enabled tools, automation, or advanced analytics, with experience implementing AI to improve processes and increase efficiency.
  • 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 system decisions.
  • Excellent written and verbal communication skills; able to produce clear documentation, user-facing guidance, and stakeholder-ready reports.
  • Experience with data reporting tools and/or data extraction (e.g., SQL, Spotfire, Power BI, or equivalent).

Preferred:
  • Experience with Veeva Vault configuration in a pharma or CRO setting, including participation in system releases, eQMS governance forums, or enhancement request management.
  • Familiarity with Pfizer enterprise data and/or source systems.
  • Exposure to data platforms - Snowflake, DSS/Dataiku - or related data engineering tools.

Working knowledge of Microsoft Power Automate or similar automation tools.
Work Location Assignment: Remote
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

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