Senior Director, IT Compliance – Governance

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🏄 California – Remote

🏄 California – Remote

💵 $75 - $86 / hour

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

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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

• Report to the Director, Quality Systems • Oversee 4DMT’s GxP Compliance Audit and Supplier Quality Management Programs • Coordinate and manage clinical site, internal, and vendor audits, including scheduling, planning, tracking, documentation, and closure • Review audit deliverables for accuracy, consistency with 4DMT standards, and GxP compliance • Track and facilitate completion of audit confirmation letters, reports, observation responses, and certificates • Ensure audit deliverables are reviewed, distributed, and archived according to procedures • Schedule pre- and post-audit meetings and coordinate auditor access to systems and documentation • Establish and update a risk-based Annual Audit Schedule and coordinate its execution • Support adequate CAPAs and Effectiveness Checks for significant audit observations and archive completion evidence • Ensure QA auditors are qualified and trained • Maintain the Approved GxP Supplier List and support supplier identification, assessment, qualification, and reassessment • Coordinate supplier risk assessments and risk-based supplier evaluation and qualification • Support compliance with the Supplier Quality Management procedure • Develop relationships with quality teams, cross-functional partners, vendors, and other functions • Develop and report audit and supplier quality metrics for Quality Assurance Management Review • Drive continuous improvement of the Quality Management System and QA processes

🎯 Requirements

• B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred • 8+ years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance, or Clinical Development/Operations within Biotech or a similar industry • Minimum 3+ years of experience in a role including responsibility for providing GxP QA oversight • Proven experience with GxP Quality Management Systems and QA audit support • Knowledge of quality investigation and root cause analysis techniques • In-depth understanding of GMP and GCP requirements for investigational products • Extensive practical experience with clinical quality assurance throughout the clinical development life cycle • Excellent oral and written communication skills • Excellent interpersonal skills and collaborative approach • Ability to work in a fast-paced small company environment with minimal direction and adjust workload to changing priorities • Willingness to travel 5% • Ability to perform sedentary work and work in typical office or administrative conditions

🏖️ Benefits

• Equal employment opportunities • 5% travel requirement • Sedentary/typical office working conditions