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 platforms).
- Regulatory Knowledge: Working knowledge of electronic workflows, document control principles, records management practices, and archiving requirements in GxP environments (e.g., GLP, GCP, GCLP).
- Emerging Technologies: Experience utilizing AI-assisted tools, automation solutions, and digital productivity platforms to improve business processes and operational efficiency.
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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.
Regulatory Affairs