Manager, GxP Quality Documents & Record Management (Contract)25652

We are seeking an experienced Manager of GxP Quality Document and Records Management to lead and support GxP documentation, records management, and training operations across various business functions. This role will serve as a strategic partner for document control and training processes, delivering compliant, efficient, and high-quality solutions that align with both business objectives and regulatory requirements.

The ideal candidate brings a strong background in GxP documentation best practices, electronic systems (DMS/LMS), and cross-functional collaboration, with a focus on operational excellence and continuous improvement.

Key Responsibilities:

• Serve as Subject Matter Expert (SME) for the GxP document lifecycle process, providing consultation and support to ensure compliance and consistency.
• Partner with leadership to enhance the document and records management system, including supporting DMS enhancements and strategic roadmaps.
• Monitor key performance indicators (KPIs) and metrics to identify opportunities for improvement.
• Manage and support Quality Events (QEs), CAPAs, and audit/inspection readiness related to documentation and records.
• Oversee the end-to-end GxP document development and control process, ensuring alignment with regulatory requirements and internal standards.
• Review and approve documentation, and support the selection of appropriate reviewers and approvers.
• Collaborate with subject matter experts (SMEs) to design, develop, and maintain GxP documentation to support key initiatives.
• Lead communication efforts to support awareness, adoption, and change management related to documentation processes.
• Act as business administrator for the Document Management System (DMS), managing configuration, validation, and system lifecycle.
• Oversee document and records lifecycle processes within the DMS.
• Act as GxP Training Administrator for the Learning Management System (LMS); maintain user groups, curricula, learning objects, and assignments.
• Manage training material workflows and version control within DMS.
• Build and maintain partnerships with GxP functional areas to align on documentation, training, and compliance expectations.
• Act as documentation SME on cross-functional projects, ensuring readiness and compliance.
• Collaborate with QA, Document Owners, and Functional Leadership to promote consistency across the organization.
• Support performance improvement through consultation, communication planning, and change management strategies.

Qualifications:

• Bachelor’s degree with 4–8 years of experience in GxP Document and Records Management, or a related quality function.
• Strong expertise in DMS administration (e.g., Veeva, DocCompliance, Documentum).
• Hands-on experience with LMS administration in a GxP-regulated environment.
• Solid knowledge of GxP regulatory requirements and quality systems.
• Proven skills in documentation development, training strategy, and cross-functional collaboration.
• Demonstrated leadership in managing documentation or training programs.

Preferred Qualifications:

• Experience with project management tools, AI/ML solutions, or learning analytics.
• Strong facilitation, communication, and influencing skills.
• Strategic thinking with the ability to drive compliance while enabling operational agility.
• Ability to manage multiple priorities in a dynamic, fast-paced environment.

• CONTRACT