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Pfizer

Manager, Quality - Digital Systems

Posted 3 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
Owns business administration and continuous improvement of Veeva Vault eQMS within a regulated pharmaceutical quality organization. Responsibilities include access management, release coordination, reporting, documentation, configuration advisory, enhancement prioritization, data operations, stakeholder communications, and cross-functional program execution. The role also evaluates AI, automation, and digital transformation opportunities while ensuring GxP compliance, data integrity, system continuity, and effective quality operations.
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Role Summary:
The Manager, Quality - Digital Systems is a business-facing role that serves as the primary point of contact between RQA's digital quality systems and the stakeholders who depend on them, with working technical depth in Veeva eQMS administration and GxP -regulated system operations anchoring that work. 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 succe ssful candidate will bring enough configuration fluency - understanding vault object relationships, shared versus instance-specific configuration, and the downstream consequences of proposed system changes - to translate technical trade-offs into clear guidance for stakeholders and support faster, better-informed decisions on enhancement requests and system design questions.
The successful candidate must communicate clearly across technical and business audiences, 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, scoping RQA's responsibilities within a given program and developing and driving the execution p lan 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 strong communication and analytical skills, working Veeva domain knowledge, genuine curiosity about applying AI and emerging technology to quality operations, and the ability to operate effectively in a regulated pharmaceutical environment - both as a business partner and as an accountable owner of complex, cross-functional work.
ROLE RESPONSIBILITIES:
Veeva eQMS Operations & Administration
  • Serve as the primary business administrator for Veeva eQMS on behalf of Regulatory Quality Assurance.

  • Triage and resolve business admin requests requiring business-level judgment, 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 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 guidance on Veeva vault configuration options in support of business needs, including object relationships, shared configuration dependencies, and the downstream impact of proposed changes, partnering with technical teams to fill configuration depth as needed.

  • Support the triage and formulation of eQMS enhancement requests, providing business 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 identify and champion opportunities to modernize system design and operations.

  • 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, including basic dashboarding and data queries, 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 drive 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:
  • Bachelor's degree in Life Sciences, Information Systems, Computer Science or a related field with 5+ years of relevant industry experience; advanced degree preferred.

  • 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.

Preferred:
  • 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 similar business-technology liaison role.

  • 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.

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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