Senior Quality Specialist (Contract)

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 leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY

4DMT is hiring a Sr. Quality Specialist, Document & Records Management. Reporting to the Senior Manager, Quality Document & Records Management, the Sr. Quality Specialist 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 will support the Senior Manager, Quality Document & Records Management 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 is hybrid and will require regularly scheduled time on-site at 4DMT's Emeryville office at least 3x a week.

RESPONSIBILITIES:

Quality Document Control & Records Management System - 50% of the time:

• Serve as the point of contact for the Document Control system and quality-controlled records management.
• Support the development, enforcement, and improvement of 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.
• Support centralized and decentralized quality-controlled record repositories (physical and electronic) for completeness, integrity, and retrievability.
• Support inspection readiness by ensuring all quality-controlled records are accessible, traceable, and compliant with data integrity and protection requirements.
• Support record audits, gap assessments, and remediation plans in preparation for regulatory inspections.
• 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.
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Quality Document Control & Records Management Operations - 50% of the time:

• Perform document intake, advanced formatting, metadata review, routing, publishing, and obsoletion and ensure timely review, approval, and release.
• Support the management of periodic reviews of controlled documents.
• 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: 

• 6+ 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., ACE, MasterControl, Veeva, etc.).
• 2+ years leading or supporting GxP records management operations.
• 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.

Travel: 75%, to Emeryville.

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 - 20 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Hourly compensation range: $51.00 - 64.00

Please note, the hourly compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.