Director – Clinical Quality Assurance

GCP Compliance

Confirmed live in the last 24 hours

4D Molecular Therapeutics

4D Molecular Therapeutics

51-200 employees

Develops gene therapy products for serious diseases


Compensation Overview

$182,000 - $240,000Annually


Oakland, CA, USA

Required Skills
Development Operations (DevOps)
Google Cloud Platform
  • B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred.
  • 10+ years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar industry
  • Proven experience with GCP Quality Management Systems for a sponsor conducting registrational studies, quality support, and quality oversight of global clinical trials
  • Minimum of 4 years of significant experience in clinical quality assurance, including experience performing/supporting GCP audits
  • In-depth understanding of GCP requirements for investigational products
  • Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle
  • Excellent communication skills, both oral and written
  • Excellent interpersonal skills, collaborative approach essential
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Provide Quality oversight for multiple 4DMT Clinical Studies
  • Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies
  • Provide guidance and support to clinical study teams
  • Ensure principles of Risk Management are applied to the Clinical Study per ICH E6
  • Identify, communicate, and escalate significant incidents of GCP non-compliance
  • Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites
  • Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs
  • Perform Clinical Document reviews
  • Support investigation and management of specific Clinical Study Quality Events
  • Support a quality-focused work environment in Clinical
  • Drive the development and continuous improvement of the Clinical Quality Management System
  • Support preparedness / readiness / management of BIMO inspections
  • Partner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues

4D Molecular Therapeutics

4D Molecular Therapeutics


4D Molecular Therapeutics, a clinical stage biopharma company, excels in genetic medicine with a focus on curative therapies across various specialties such as ophthalmology, pulmonology, and cardiology. They leverage a unique vector discovery platform, Therapeutic Vector Evolution, which employs directed evolution to design uniquely effective vectors. This commitment to tailored therapeutic solutions and cutting-edge technology makes it an exceptional workplace for professionals passionate about pioneering in the field of genetic medicine and contributing to significant advancements in healthcare.

Company Stage


Total Funding



Emeryville, California



Growth & Insights

6 month growth


1 year growth


2 year growth