Associate Director, QA Computer System Validation
About The Position
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY The Associate Director, QA Computer System Validation (QA CSV) is responsible for overseeing the validation, compliance, and lifecycle management of GxP computerized systems. This role ensures systems are compliant with applicable regulations and industry standards (e.g., FDA 21CFRPart11, EU Annex 11, GAMP 5, applicable ICH Guidelines) and supports business objectives through risk-based, compliant validation strategies. The position provides strategic QA leadership, partners cross-functionally with business partners and IT vendors to ensure appropriate Quality oversight of CSV activities and data integrity controls throughout the lifecycle of 4DMT’s GxP computerized systems.
Requirements
- Bachelor’s degree in life sciences, business or related field.
- 9+ years of experience within the biopharmaceutical industry, preferable in both large and small company environments
- 6+ years’ experience in QA CSV
- Thorough working knowledge of computer systems validation and computer software assurance.
- Expertise in 21CFRPart11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practices.
- Hands-on experience in implementing and maintaining data integrity controls.
- 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 that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent written and verbal communication skills; strong interpersonal skills.
Responsibilities
- Provide QA oversight and support business and CSV activities throughout the lifecycle of GxP computerized systems.
- Review and approve CSV deliverables, IT change management requests, and quality records (e.g., NCRs CAPAs) to ensure adherence to 4DMT’s internal procedures and policies, and applicable regulatory requirements and standards.
- Review plans and provide day-to-day QA guidance and support to initial validation, steady state activities and controlled change-related initiatives of GxP systems.
- Serve as a subject matter expert (SME) in CSV requirements, data integrity controls, and related regulatory requirements / standards, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH Guidelines.
- Develop and/or refine QA and CSV-related procedures and templates.
- Support audits for qualification and requalification of IT vendors.
- Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
- Support inspection readiness initiatives, audits and regulatory inspections.
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
