Job description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
Company Differentiators:
• 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
GENERAL SUMMARY:
4DMT is hiring a Sr. Manager, Quality Document & Records Management. Reporting to the Sr. Director of Quality Systems and GCP Compliance, the Sr. Manager will be responsible for ensuring 4DMT’s Quality Document & Records Management is designed and executed in an efficient, compliant, and inspection ready manner.
This individual serves as the process owner for the quality document and records management system, ensuring compliance with applicable GxP regulations, industry standards, and internal policies. In addition to driving process improvements and system optimization, this role will perform operational tasks to support document and record lifecycles.
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.
RESPONSIBILITIES:
Quality Document Control & Records Management System & Process Owner - 50% of the time:
- 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.
Quality Document Control & Records Management Operations - 50% of the time:
- 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.
QUALIFICATIONS:
Education:
- Bachelor’s degree required, preferably in a scientific, technical, or related field.
Experience:
- 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.
Skills:
- 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
Key Competencies
- 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.
Base salary compensation range: $160,000/yr - $210,000/yr
Please note that compensation varies based on individual experience, location, skillset, etc.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
