Senior Director, Clinical Quality Assurance

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $245k - $286k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Provide strategic and operational Quality Assurance leadership and oversight for multiple registrational, global 4DMT-sponsored clinical trials • Serve as a senior Quality partner to clinical study teams and leadership, providing guidance on GCP, ICH E6, related regulations, decision support, and escalation recommendations • Lead development, implementation, and governance of Clinical Study Quality Plans • Manage, mentor, and develop Clinical QA staff and consultants • Define, plan, perform, and/or oversee risk-based GCP compliance audits of high-risk clinical vendors and sites • Communicate audit findings, quality risks, and CAPA commitments; assess CAPA adequacy and escalate unresolved or recurring issues • Provide senior Quality review and strategic input on clinical and regulatory documents • Lead investigation and management of significant Clinical Study Quality Events and oversee corrective and preventive actions • Partner with CMC Quality, Clinical Operations, and senior cross-functional stakeholders to resolve clinical supply quality issues • Oversee GCP compliance training and strengthen clinical quality culture and inspection readiness • Partner with Clinical Operations, Clinical Development, Biometrics, Data Management, Medical Affairs, and Regulatory Affairs on proactive quality and risk management • Lead development and continuous improvement of the Clinical Quality Management system • Define and lead GCP inspection readiness strategy, mock inspections, logistics, and issue escalation • Host, lead, and/or provide senior Quality support for GCP-related inspections

🎯 Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or related field • 12+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar industry, or an advanced degree with 10+ years of experience • Minimum of 7 years of significant experience in clinical quality assurance • Proven experience leading Clinical quality strategy, quality governance, and senior-level quality oversight of global clinical trials and associated vendors • Experience hosting, leading, and supporting health authority inspections, including inspection readiness preparation, front-room/back-room support, response coordination, and follow-up commitment management • Extensive practical experience and understanding of clinical quality assurance applied throughout the clinical development life-cycle • Demonstrated ability to influence senior cross-functional stakeholders, lead complex clinical quality initiatives, and provide mentorship or functional leadership within Clinical QA • Expert understanding of GCP requirements for investigational products and ability to interpret and apply requirements strategically across clinical programs • Executive-level oral and written communication skills • Strong leadership, influencing, and interpersonal skills, with a collaborative approach • Ability to operate independently in a fast-paced small company environment, prioritize complex workstreams, make risk-based decisions with minimal direction, and adjust quickly to changing priorities