Full-Time

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

Biotechnology

Compensation Overview

$182,000 - $240,000Annually

Senior

Oakland, CA, USA

Required Skills
Management
Development Operations (DevOps)
Google Cloud Platform
Requirements
  • 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
Responsibilities
  • 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

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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

IPO

Total Funding

$595M

Headquarters

Emeryville, California

Founded

2013

Growth & Insights
Headcount

6 month growth

18%

1 year growth

20%

2 year growth

38%