Director, Clinical Quality Assurance – CQA

4D Molecular Therapeutics

Director of Clinical Quality Assurance at 4D Molecular Therapeutics ensuring compliance in global clinical trials. Collaborating with teams to enhance quality and safety in biotechnology research.

Posted 4/22/2026full-timeRemote • 🇺🇸 United StatesLead💰 $205,000 - $235,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities:
Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies, focused on ensuring subject safety/rights, study data integrity, and GCP compliance.
Provide guidance and support to clinical study teams, including via attendance at Study team meetings and via investigation and management of Clinical Study Quality Events.
Ensure principles of Risk Management are applied to the Clinical Study per ICH E6.
Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency.
Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator 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, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries.

Requirements

What you’ll need

S./B.A. degree in a science or related life science field or equivalent; advanced scientific degree preferred.
10+ years of experience or advanced degree with 7+ years of experience 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, 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 and overseeing global clinical trials, including in APAC.
Extensive practical experience and understanding of clinical quality assurance as applied throughout the clinical development life-cycle
(Optional) 5+ years of management experience or other specific work experience.
In-depth understanding of GCP requirements for investigational products.
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 to workload based upon changing priorities.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCP complianceClinical Study Quality PlansRisk ManagementGCP Compliance auditsClinical Document reviewsQuality Management SystemsClinical quality assuranceCAPAsClinical ProtocolsPharmacovigilance

Soft Skills

communication skillsinterpersonal skillscollaborative approachability to adjust to workloadsense of urgency