4D Molecular Therapeutics
biotechnology
SeniorQualitySpecialist(Contract)
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Quality Specialist (Contract) at 4D Molecular Therapeutics. Skills: Document control, Records management, GxP compliance. Ensure quality document records management efficient compliant. Support quality document records management system”
Industry & Context.
Problem-solving
3x week onsite, 75% travel Emeryville
What They're Looking For.
Must Have
Bachelor's degree required, 6+ years experience document control, 2+ years GxP EDMS ownership, 2+ years GxP records management operations, Comprehensive knowledge FDA EMA ICH, 1+ EDMS EQMS system implementation
Nice to Have
Scientific technical related field degree, Domain knowledge clinical research, Domain knowledge development, Domain knowledge manufacturing, Domain knowledge quality, Domain knowledge IT, Exposure audits health authority inspections, Commercializing biotech environment experience
What You'll Do.
Ensure quality document records management efficient compliant
Support quality document records management system
Perform operational tasks support lifecycles
Serve point contact document control system
Support development enforcement improvement policies
Collaborate stakeholders align record policies
Support quality-controlled record repositories
Support inspection readiness records accessible traceable
Support record audits gap assessments
Monitor trend report document control metrics
Support internal external audits inspections
Provide guidance training system users
Perform document intake advanced formatting
Ensure timely review approval release
Support management periodic reviews
Advise document control participants
Ensure compliance document control procedures
Collaborate Quality Training coordinate lifecycles
Facilitate quality-controlled records management
Identify implement innovative methods efficiency
How You'll Work.
Team & Collaboration
Collaborate stakeholders; Collaborate Quality Training
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management, Organizational skills
Full 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 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 op
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