Senior Manager, Quality Document & Records Management

Summary

Join 4DMT as a Sr. Manager, Quality Document & Records Management and ensure the company's Quality Document & Records Management system is efficient, compliant, and inspection-ready. You will serve as the process owner, ensuring compliance with GxP regulations and industry standards. Responsibilities include developing and improving policies and procedures, overseeing record repositories, driving inspection readiness, leading audits, and providing user training. Operational tasks involve document intake, formatting, and routing. This role requires significant experience in document control and records management within the biotech/pharmaceutical industry, along with leadership and management experience. The position offers a hybrid work model with a base salary range of $160,000 to $210,000 per year.

Requirements

• Bachelor’s degree required, preferably in a scientific, technical, or related field
• 8+ years of experience in document control and records management within the biotech, pharmaceutical, or medical device industry
• 2+ years in a hands-on system and/or process ownership role for a GxP EDMS (e.g., Veeva, MasterControl, ACE)
• 2+ years leading or supporting GxP records management operations
• 4+ management experience
• Comprehensive knowledge of FDA, EMA, ICH requirements and industry best practices for document control and records management
• Practical experience leading or actively participating in at least 1 EDMS or EQMS system implementation and/or significant enhancement project
• Exposure to audits and health authority inspections ideally in a commercializing biotech environment
• Extensive experience in document formatting using MS Word
• Solid working proficiency in other productivity tools (e.g., Outlook, Teams, SharePoint, Excel, PowerPoint, Forms, DocuSign, Adobe Acrobat)
• Basic knowledge of or willing to learn analytical and reporting tools (e.g., PowerBI)
• Foundational understanding of change management principles
• Excellent interpersonal communication skills both written and verbal
• Highly organized with the ability to multi-task and perform effectively under pressure
• Proven project management, problem-solving, and organizational skills
• Demonstrated ability to collaborate, influence, and negotiate effectively
• Motivated to seek out training and mentorship for professional development

Responsibilities

• Serve as the primary point of contact for the Document Control system and quality-controlled records management
• Develop, enforce, and improve policies, procedures, work instructions, templates, and forms related to document and records management
• Collaborate closely with stakeholders (e.g., legal, clinical, regulatory, IT) to align record policies and lifecycles across platforms
• Oversee centralized and decentralized quality-controlled record repositories (physical and electronic) for completeness, integrity, and retrievability
• Drive inspection readiness by ensuring all quality-controlled records are accessible, traceable, and compliant with data integrity and protection requirements
• Lead or support record audits, gap assessments, and remediation plans in preparation for regulatory inspections
• Lead user requirement definition, system change verification, validation document review, and user training
• Monitor, trend and report document control metrics (e.g., cycle time, overdue documents)
• Support internal and external audits and inspections
• Provide guidance and training to system users and support documentation governance across departments
• Hire, manage and develop staff and/or contractors
• Perform document intake, formatting, metadata review, routing, publishing, and obsoletion and ensure timely review, approval, and release
• Advise document control participants on content and format to meet 4DMT procedural requirements, standards, templates, and best practices
• Ensure compliance with document control procedures and applicable regulations
• Collaborate with Quality Training to coordinate document and training lifecycles
• Facilitate quality-controlled records management (e.g., onsite and off-site secure storage, retention, destruction)
• Identify and implement innovative methods to increase efficiency of operational tasks

Preferred Qualifications

Domain knowledge of clinical research and development, manufacturing, quality, and/or IT is highly desirable

Benefits

• Base salary compensation range: $160,000/yr - $210,000/yr
• This role can be in-person or hybrid. If Hybrid, the role will require regularly scheduled time on-site at 4DMT's Emeryville office at least monthly