Document Control & Training Manager

Enigma Search • Alameda, CA

10d

About The Position

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. In this pivotal role, you'll be the go-to expert for all things related to document control and training.

Requirements

• 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.

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Manager