US_East | QA / Quality Manager _L3

Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential

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GTD: 5TTSG8

Role: Organization Change Management Lead

Work Location: Richmond, VA

Job Description

Responsible for overseeing the management and control of quality-related documents within an organization. The role involves ensuring compliance with regulatory standards, establishing and maintaining efficient document control systems, and providing support to teams across the organization. This includes managing the lifecycle of documents, from creation and review to approval, archiving, and eventual disposal, while maintaining version control and ensuring easy retrieval of documents for audits and inspections. Strong organizational, regulatory, and technical skills are critical for success in this role, along with the ability to manage cross-functional collaboration and drive continuous improvement in document control processes.

• Develop and Maintain Document Control Systems & Version Control 2. Oversee the process for document creation, review, approval, and distribution, ensuring that documents meet organizational and regulatory requirements. 3. Coordinate with various departments to ensure that documents are reviewed by appropriate subject matter experts (SMEs) and signed off by authorized personnel before they are finalized and implemented. 4. Ensure that approval workflows are followed in compliance with regulatory requirements, including GxP (Good Manufacturing Practices) 5. Offer support to teams in creating and revising documents, ensuring consistency, clarity, and compliance with organizational and regulatory standards. 6. Oversee the complete lifecycle of documents, from creation and revision to archiving and eventual disposal, ensuring compliance with retention policies. 7. Integrate the document control system with the broader Quality Management System (QMS) to ensure that documents are aligned with quality objectives and processes. 8. Collaborate with internal onshore and offshore teams (e.g., quality assurance, regulatory affairs, R&D, manufacturing) to ensure that all quality documents are aligned with the organizations overall quality strategy. 9. Ensure that documents are standardized across the organization, with consistent formats and terminology. 10. Defining training requirements and subject matter content to be administered on a local level. Develop training and deploy training and monitor compliance. 11. Provide training to employees on document control processes and best practices to ensure they understand how to manage and use documents effectively.
  
  

" A bachelors degree in a related field such as Quality Management, Business Administration, Life Sciences, For Engineering. " Experience in quality document control, quality assurance, or a related area within a regulated industry (e.g., pharmaceuticals, medical devices, food safety, manufacturing) " 5-10 years of Quality / relevant process experience in regulatory environment " 3-8 years of people leadership. " Ability to lead and manage an onshore and offshore team " Excellent project management skills in defining scope, schedules, and resources to ensure consistent quality " Excellent communication and presentation skills with ability to influence people at all levels of the organization " Ability to identify and resolve document-related issues, whether it's improving workflows, resolving document

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