Senior QA Computer System Validation Manager

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $126k - $145k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Oversee validation, compliance and lifecycle management of GxP computer systems projects across GCP, GMP and GLP environments. • Provide QA oversight for business and CSV activities throughout the lifecycle of GxP computer systems. • Provide Quality oversight of GxP computerized systems operated, hosted or maintained by external partners or vendors. • Review and approve CSV deliverables, IT change management requests and quality records such as NCRs and CAPAs. • Review plans and provide day-to-day QA guidance for initial validation, steady-state activities and controlled changes to GxP systems, with focus on clinical systems. • Serve as subject matter expert in CSV requirements, data integrity controls and related regulatory standards. • Assist in developing or refining QA and CSV procedures and templates. • Support qualification and requalification audits of IT vendors. • Collaborate across functions and within Quality to identify improvements and implement enhancements. • Support inspection readiness initiatives, audits and regulatory inspections. • Perform other duties as assigned by management.

🎯 Requirements

• Bachelor’s degree in life sciences, computer science, business or related field. • Minimum 5-7 years of experience within the biopharmaceutical industry, preferably in both large and small company environments. • Minimum 4 years experience in QA CSV. • Strong experience supporting computer systems used in clinical trials through all phases of development. • Extensive experience supporting validation of clinical systems (e.g. IRT, EDC, eTMF). • Thorough working knowledge of computer systems validation and computer software assurance. • Experience with enterprise, quality, lab and clinical systems ensuring compliance with FDA, EMEA, MHRA and other regulatory requirements. • Expertise in ICH guidelines, 21 CFR Part 11, EU Annex 11, data integrity and GAMP 5 concepts, application and best practices. • Experience supporting regulatory inspections and audits. • Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation and maintenance. • Experience working with all levels of management and consulting with key business stakeholders. • Strong team player with a customer service approach and solution-oriented mindset. • Attention to detail and ability to work independently, within a multi-disciplinary team, and with external partners and vendors. • Excellent written and verbal communication skills; strong interpersonal skills. • Travel as needed, less than 5%. • Sedentary work capability and ability to work in typical office or administrative conditions.