Associate, Quality Records

About this role

Use Your Power for Purpose At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care.

What You Will Achieve Under the direction of the Senior Manager, Quality Records & Training Compliance, the Associate, Quality Records is responsible for ensuring the compliant execution of electronic workflows, records governance, and document management processes supporting Research & Development Vaccines programs. This role serves as a key administrator and coordinator for reports, archives, and procedural documentation within electronic document management systems (e.g., GDMS, Gnosis, Veeva, and ValGenesis), while also managing user access, governance, and compliance activities within Electronic Laboratory Notebooks (ELNs), including Revvity Signals and GLP Signals. The associate will actively participate in and drive continuous improvement initiatives by identifying opportunities to streamline administrative processes and automate manual workflows through AI-enabled and other digital technology solutions.

This role requires strong organizational, project management, and technical skills. The ideal candidate will possess a solid understanding of records management principles, archival compliance requirements, and submission-ready documentation standards. The Associate, Quality Records will also champion compliance initiatives by providing training, knowledge transfer, and customer support across all levels of the organization, including senior scientific leadership, to promote the effective, efficient, and compliant use of documentation and quality systems.

How You Will Achieve It

Document & Workflow Management • Leverage and manage electronic workflows across key document management systems (GDMS, Gnosis, Veeva, and ValGenesis) to support the creation, review, approval, and archiving of reports, procedures, and other controlled documentation for Vaccine programs.

• Execute document control activities, including metadata assignment, version control, status tracking, and document lifecycle management, ensuring accuracy, compliance, and timely execution.

Compliance & Records Governance

• Ensure compliance with departmental procedures, global records management requirements, and applicable regulatory standards, including Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).

• Support quality records audit readiness activities and data integrity initiatives.

• Contribute to records governance and retention practices to ensure documentation is maintained in accordance with regulatory and business requirements.

Systems Administration & ELN Support

• Administer Electronic Laboratory Notebook (ELN) operations, including user access management, onboarding, troubleshooting, compliance monitoring, template management, and system enhancement projects.

• Serve as a primary point of contact for system-related issues, partnering with digital and business teams to resolve technical challenges and drive continuous system improvements.

Training & Stakeholder Enablement

• Develop and deliver training, guidance, and customer support to the Vaccines scientific community on document management systems, procedural documentation practices, and compliance requirements.

• Build strong partnerships and communicate effectively with stakeholders across all organizational levels, including senior scientific leadership, to promote compliant and efficient business practices.

• Support knowledge transfer initiatives and drive user adoption of new processes and technologies.

Continuous Improvement & Digital Enablement • Champion innovation and digital transformation by identifying and implementing AI-enabled, automated, and technology-driven solutions that streamline processes and reduce manual effort.

• Contribute to continuous improvement initiatives by identifying process bottlenecks, optimizing document workflows, and supporting records governance and archiving projects.

• Demonstrate adaptability and a growth mindset in responding to evolving business needs, emerging technologies, and changing regulatory requirements.

• Promote operational excellence through process simplification, standardization, and automation opportunities.

Qualifications

Must-Have • Education: Bachelor's degree in a scientific, technical, business-related, or other relevant discipline.

• Software Proficiency: Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat Professional.

• Digital Fluency & Innovation: Technology-savvy with a strong aptitude for adopting and leveraging AI-enabled and digital solutions to streamline workflows, reduce manual effort, and drive continuous improvement.

• Communication: Strong verbal and written communication skills, with the ability to effectively translate technical processes, workflows, and compliance requirements for diverse stakeholder groups.

• Organization: Excellent organizational, planning, and time management skills, with the ability to manage multiple priorities and consistently meet deadlines in a fast-paced environment.

• Mindset: Self-motivated and capable of working independently with minimal supervision while fostering a collaborative, team-oriented approach.

• Attention to Detail: Demonstrated attention to detail and commitment to data integrity, quality, compliance, and accuracy.

Nice-to-Have • Industry Experience: Experience working in a highly regulated environment, such as pharmaceutical, biotechnology, medical device, or life sciences.

• Documentation Systems: Experience with electronic document management systems and repositories (e.g., GDMS, Veeva Vault, ValGenesis, Gnosis, or similar p

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