Sr Manager, Quality Document & Records management

• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine

• 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.

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

• 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.

4DMolecularTherapeutics