Senior Quality Specialist (Contract)

4D Molecular Therapeutics•Emeryville, CA

7h•$51 - $64•Hybrid

About The Position

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.

Requirements

Bachelor’s degree required, preferably in a scientific, technical, or related field.
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.
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.

Nice To Haves

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

Responsibilities

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.
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.