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
The Sr. QA Computer System Validation Mgr. is responsible for overseeing the validation, compliance and lifecycle management of GxP computer systems projects across GCP, GMP and GLP environments. This includes clinical, quality, laboratory, enterprise and manufacturing systems to ensure systems are compliant with applicable regulations and industry standards (e.g. FDA, 21CFR Part11, EU Annex 11, GAMP 5, applicable ICH Guidelines) and supports business objectives through risk-based, compliant validation strategies.
This role partners cross-functionally with business partners and IT vendors to ensure validated systems remain compliant throughout its lifecycle and provide appropriate Quality oversight of CSV activities of 4DMT’s GxP computer systems.
MAJOR DUTIES & RESPONSIBILITIES:
QUALIFICATIONS:
Education:
Experience:
Other Qualifications/Skills:
Travel: As needed, less than 5%
Physical Requirements and Working Conditions:
Base salary compensation range: $126,000 - 145,000
Please note, the base salary 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.
Hybrid working - our approach is to be in the office or on client site a minimum of 2 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client.
Gerencia e executa validações de processos assépticos, incluindo filtração esterilizante e esterilização por radiação, conduz investigações e auditorias e apoia a qualidade e conformidade dos processos.
Maintain and improve the laboratory Quality Management System, coordinate audits and corrective actions, monitor quality performance, and support compliance with medical testing standards across laboratory operations.
Conduct internal investigations into employee theft, fraud, policy violations, and other risks across retail operations, using data analysis, interviews, evidence management, and clear reporting to support resolution.
Oversee EU and UK pharmacovigilance systems, ensure timely and complete responses to regulatory authorities, and maintain oversight of product safety profiles, emerging concerns, and safety commitments.
