About the job Document Control & Training Manager
Join a Leading Cell & Gene Therapy Company as a Document Control & Training Manager!
Are you a highly organized and detail-oriented Quality Assurance professional with a passion for building robust document control and training systems? Our client, a leader in cell and gene therapy manufacturing, is seeking a Document Control & Training Manager .
This is a fantastic opportunity to join a fast-paced environment where you will lead and implement document management and training processes from the ground up, ensuring full compliance with GxPs and supporting life-saving therapies. If you are a hands-on professional with expertise in Veeva QualityDocs and a knack for cross-functional collaboration, we want to hear from you.
What You'll Work On
In this pivotal role, you'll be the go-to expert for all things related to document control and training. Your responsibilities will include :
- Managing and coordinating all document control activities and processes for the quality and manufacturing organizations.
- Leading compliance and continuous process improvement efforts within the Document Control framework.
- Overseeing the entire document lifecycle, including processing, formatting, and issuing documents for training, ensuring accuracy and efficiency.
- Supporting the reconciliation and archiving process for all paper documents.
- Reviewing Document Change Controls to ensure proper revision control and closure.
- Managing the document periodic review process and coordinating with stakeholders for timely completion.
- Performing Business Administrator activities in the electronic document management system ( Veeva QualityDocs ).
- Executing user test scripts for system changes in the EDMS.
- Managing Learner Roles, curriculums, and training requirements in the Learning Management System ( Veeva Training ).
- Supporting all onsite audits and regulatory or client inspections.
- Contributing to other quality system improvement projects, including those related to the Veeva eQMS system .
What You'll Contribute
A Bachelor's degree or higher.A minimum of 5-10 years of experience in a quality assurance role within the pharmaceutical industry.Strong, hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) , with a strong preference for Veeva QualityDocs and Veeva Training .Excellent knowledge and understanding of applicable GxP regulations .Demonstrated experience in identifying and resolving Good Documentation Practices (GDP) issues.Familiarity with standard software such as the Microsoft Office Suite, DocuSign, Smartsheet, SharePoint, and Adobe Pro.Exceptional attention to detail, strong technical writing skills, and the ability to work independently with minimal supervision.Excellent organizational, interpersonal, and communication skills, with a strong sense of teamwork.