Documentation Specialist

About this role

Job Title : Documentation Specialist • Location: Swiftwater, PA  

About the Job The Documentation Management function sits within the Quality System job family, specifically under the Quality Content Management System (CMS), Quality Systems, job category. This team is part of the broader Quality organization that covers Quality Control, Quality Audit, Regulatory Compliance, and Quality Risk Management. The Documentation Management team is responsible for managing the lifecycle of Quality documents and records in compliance with good documentation practices. Keeping current, optimizing, and simplifying documentation to ensure Sanofi compliance with regulations and facilitates record retention archiving procedures on behalf of the Swiftwater entity. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.   Main Responsibilities • Managing the GxP documentation lifecycle (creation, revision, and obsolescence

• Collaborating with other departments to ensure document content addresses the business needs and processes

• Ensuring, with the support of relevant experts that the documentation content is compliant with regulatory requirements and company standards

• Ensuring the overall documentation package is kept lean (i.e., avoiding redundancies and duplication)

• Ensuring accuracy, completeness, and compliance of the documentation with writing rules (incl. clarity and grammar)

• Collecting needs for documentation changes, prioritizing and managing document updates

• Ensuring the documentation is regularly updated to remain current and aligned with the needs and processes

• Ensuring document distribution and access complies with the information classification level

• Supporting internal and external audits and inspection by ensuring all required documents are up-to-date and retrievable

• Supports record retention archiving procedures as a Business Archives Coordinator (BAC) on behalf of the Swiftwater site

• Acts as liaison with approved third-party storage subcontractors

• Provides guidance on archiving tools and processes

• Supports annual archival eligibility reviews

Key Roles (D, A, I) • Establish and maintain documentation systems (D)

• Decide on compliance-related actions (D)

• Advise on documentation update needs (A)

• Advise on document access needs (A)

Additional Accountabilities To locally support M&S Swiftwater site: • Site Representation & Communication: Serves as the site's backup representative for the CMS Community of Practice (CoP) and participates in Centers of Excellence (CoE) when requested, ensuring effective local communication and knowledge transfer

• Third-Party Storage Coordination: Acts as support liaison with approved third-party vendors for off-site storage activities, ensuring compliance with records retention requirements

• Leadership & Project Support

• Provides supervisory support on behalf of management as needed and serves as team member or lead for cross-functional improvement initiatives and project teams

• Training & User Support: Delivers advanced guidance to CMS users and conducts specialized training sessions on documentation management processes and best practices

• Access Management: Processes CMS Care access requests for all user roles (excluding Consumer level) to ensure appropriate system permissions

• Priority Reporting & Monitoring: Issues weekly high-priority Document Change Request (DCR) reports to ensure timely implementation

• MOSAIC Governance Support: Supports documentation governance activities in alignment with MOSAIC project requirements and objectives

• Fly (Paperless) Deployment Program Support: Coordinates local project timelines and deliverables across multiple stakeholders. Serves as a point of contact for business users regarding Fly-related inquiries and support needs; Builds and maintain strong relationships with cross-functional teams and ensures clear, concise project communications to diverse audiences

• Document Lifecycle Management: Distributes periodic review reports to ensure maintaining compliance with global and regulatory requirements. Initiates reconciliation processes for superseded or obsoleted paper logbooks.

About You

Basic Qualifications • Bachelor's degree preferred.

• Minimum of 4 years of experience in document management, continuous improvement methodologies, and cross-functional process involvement. In pharmaceutical industry preferred.

Preferred Qualifications • Demonstrated experience leveraging digital tools and AI-enabled platforms to streamline documentation workflows, automate routine tasks, and improve data accuracy and retrieval efficiency.

• Working knowledge of content management systems (CMS) and digital lifecycle management platforms (e.g., Veeva Vault), with the ability to quickly adapt to new digital and AI-driven tools as they are introduced.

• Familiarity with AI-assisted document processing capabilities (e.g., intelligent search, automated classification, optical character recognition/OCR, generative AI for content drafting or summarization) is highly valued.

• Comfort working within paperless and digital transformation initiatives (e.g., Fly deplo

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