Senior Manager, Audit and Supplier Management – Contract

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $75 - $86 / hour

⏳ Contract/Temporary

🟠 Senior

🛒 Procurement

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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 and contribute to 4DMT’s Quality Assurance and Compliance mission, objectives, and strategic plan • Operationally manage the GxP Compliance Audit Program and Supplier Quality Management Program • 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 audit confirmations, reports, observation responses, and certificates • Ensure audit deliverables are reviewed, distributed, and archived according to procedures • Schedule pre- and post-audit meetings and ensure auditors have required system access and documentation • Establish and update the risk-based Annual Audit Schedule and coordinate its execution • Collaborate on CAPAs and Effectiveness Checks for significant audit observations and collect/archive completion evidence • Ensure QA Auditors are qualified and trained • Maintain the Approved GxP Supplier List and coordinate supplier identification, assessment, qualification, and reassessment • Manage supplier risk assessments and ensure risk-based supplier evaluation and qualification requirements are executed • Develop audit and supplier quality metrics for Quality Assurance Management Review reporting • Support 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 in a role including responsibility for 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 as priorities change • Sedentary-work physical requirements and typical office/administrative working conditions

🏖️ Benefits

• Hourly compensation range of $75.00–$86.00/hr • 5% travel requirement