Senior Manager, GxP Documentation and Records Management

4 weeks ago


Norwood, Massachusetts, United States Moderna, Inc. Full time

As a Senior Manager, GxP Documentation and Records Management, you will oversee the management and maintenance of our GxP documentation and records system and processes across our global GxP organization.

Maintain and continuously improve our comprehensive global strategy for GxP documentation and records management, ensuring compliance with regulatory requirements and industry best practices reflected in the relevant policies, procedures, and associated documentation.

Provide strategic direction and guidance to global and local teams supporting document control, records management and archival as well as cross-functional teams on document control, document lifecycle management, and records management processes.

Engage with Digital Business Partners to establish a cohesive roadmap supporting the compliance and dynamic business needs of the electronic document management system.

Act as the Quality Systems Document Control and Records management Subject Matter expert for internal stakeholders and in support of third party audit and external health authority inspections.


GxP Documentation Management:

Oversee the creation, review, approval, and revision of GxP documents, including Standard Operating Procedures (SOPs), protocols, batch records, and other controlled documents.

Ensure document control procedures are in place and followed, maintaining the accuracy, integrity, and availability of GxP documents.
Collaborate with stakeholders to establish and maintain document templates, formatting standards, and version control systems.

Records Management:

Maintain and improve the global records management program, including the classification, retention, and disposition of GxP records in compliance with regulatory requirements throughout the complete document lifecycle including chain of custody and associated data integrity.

Manage controls for long term storage and required retention periods.

Stay up to date with evolving regulatory requirements and industry trends related to records management and implement necessary changes to maintain compliance.


Training and Compliance:

Develop and deliver training programs on GxP documentation and records management to ensure employees understand and adhere to relevant procedures and guidelines.

Oversee the periodic review process of controlled documents and related content.
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Identify opportunities for process improvement and automation in GxP documentation and records management, leveraging technology solutions and machine learning capabilities.

Lead or participate in cross-functional initiatives to enhance efficiency, accuracy, and compliance in document and records management practices.


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