Sr. QA Computer System Validation Mgr.

About the role

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.

The Sr. QA Computer System Validation Manager is responsible for overseeing the validation, compliance and lifecycle management of GxP computer systems projects across GCP, GMP and GLP environments. This includes clinical, quality, laboratory, enterprise and manufacturing systems to ensure systems are compliant with applicable regulations and industry standards (e.g., FDA, 21 CFR Part 11, EU Annex 11, GAMP 5, applicable ICH Guidelines) and supports business objectives through risk-based, compliant validation strategies. This role partners cross-functionally with business partners and IT vendors to ensure validated systems remain compliant throughout their lifecycle and provide appropriate Quality oversight of CSV activities of 4DMT’s GxP computer systems.

Responsibilities

• Provide QA oversight to support business and CSV activities throughout the lifecycle of GxP computer systems
• Provide Quality oversight of GxP computerized systems not directly managed by 4DMT, including systems operated, hosted, or maintained by external partners or vendors, and review and approve CSV deliverables in adherence to applicable vendor or external partner procedures
• 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 and steady state activities and controlled change-related initiatives of GxP systems with focus on clinical systems
• Serve as 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
• Assist in development and/or refinement of 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 or reassigned as needed by management

Requirements

• Bachelor’s degree in life sciences, computer science, business or related field

Qualifications

• Minimum 5–7 years of experience within the biopharmaceutical industry, preferably in both large and small company environments
• Minimum 4 years of experience in QA CSV
• Strong experience supporting computer systems used in clinical trials through all phases of development
• Extensive experience supporting the 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 and EU Annex 11 regulations, 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

Other Qualifications / Skills

• 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 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

Physical Requirements and Working Conditions

• Physical Requirements: Sedentary work involving sitting most of the time; exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently
• Working Conditions: Not substantially exposed to adverse environmental conditions (typical office or administrative work environment)

Pay

Base salary compensation range: $126,000 – $145,000. The actual salary offered depends on candidate’s geographical location, relevant work experience, skills, and years of experience.