---
title: 'Sr. QA Computer System Validation Mgr. at 4D Molecular Therapeutics'
canonical: 'https://feeny.ai/job/sr-qa-computer-system-validation-mgr-4d-molecular-therapeutics-united-states-aq7bmg1j30ra'
type: 'job'
last_seen: '2026-09-13'
---

# Sr. QA Computer System Validation Mgr. at 4D Molecular Therapeutics

- **Company:** 4D Molecular Therapeutics
- **Location:** United States
- **Work type:** remote
- **Posted:** 2026-08-28
- **Last confirmed live:** 2026-09-13
- **Apply:** https://4dmoleculartherapeutics.com/careers/?gh_jid=4728433005

## Job description

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

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 Sr. QA Computer System Validation Mgr. 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, 21CFR Part11, 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 its lifecycle and provide appropriate Quality oversight of CSV activities of 4DMT’s GxP computer systems.

## MAJOR DUTIES & 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 refined 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 improvements and implement enhancements
- Support inspection readiness initiatives, audits and regulatory inspections
- Other duties as assigned or reassigned as needed by management

## QUALIFICATIONS:

Education:

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

Experience:

- Minimum 5-7 years of experience within the biopharmaceutical industry, preferable 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 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, 21CFR Part 11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practice
- Expertise in 21CFRPart11 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 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

Travel: As needed, less than 5%

Physical Requirements and Working Conditions:

- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $126,000 - 145,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

## About 4D Molecular Therapeutics

## Company Overview
- **One-liner**: 4D Molecular Therapeutics is a late-stage clinical biotechnology company inventing and developing customized genetic medicines using a proprietary vector evolution platform to treat large-market diseases.
- **Entity Type**: Public (NASDAQ: FDMT)
- **Headquarters**: Emeryville, California, United States
- **Founded**: 2013
- **Founders**: David Kirn, MD (Co-Founder, President, and CEO)

## Core Business
- **Primary industry**: Biotechnology / Genetic Medicine / Gene Therapy
- **Target customers**: B2B (partnerships with other biopharma companies) and B2C (patients with retinal and pulmonary diseases)
- **Mission or purpose statement**: "To unlock the full potential of genetic medicines for large market diseases" by harnessing directed evolution to invent customized and enhanced vectors for transformative products.

## Products & Services
- **4D-150**: A clinical-stage genetic medicine candidate for retinal vascular diseases (wet age-related macular degeneration and diabetic macular edema). It is designed as a single, routine, low-dose intravitreal injection that provides multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C). Currently in Phase 3 clinical trials (4FRONT-1 and 4FRONT-2) for wet AMD and Phase 1/2 for DME.
- **4D-710**: An investigational genetic medicine candidate for cystic fibrosis lung disease. It uses the A101 vector for aerosol delivery of a corrective CFTR transgene (CFTR∆R) and is designed for patients ineligible for or who have discontinued CFTR modulator therapy. Currently in Phase 1/2.
- **4D-175**: A preclinical candidate for geographic atrophy (a form of dry AMD) using the R100 vector to deliver a shortened form of human complement factor H (sCFH) to restore normal complement regulation.
- **4D-725**: A preclinical candidate for alpha-1 antitrypsin (A1AT) lung disease using the A101 vector for aerosol delivery.

## Market Standing
- **Valuation/Market Cap**: $756.4 million (as of latest data from LinkedIn)
- **Key Metric**: Annual Revenue of $85.2 million (as of latest data from LinkedIn)
- **Notable Investors/Partners**: The company is publicly traded (IPO in 2020). Key partnerships are sought for pipeline candidates like 4D-175 and 4D-725.
- **Growth Signals**: The company is a late-stage biotech with two Phase 3 trials (4FRONT-1 and 4FRONT-2) for its lead candidate 4D-150 in wet AMD, and a Phase 1/2 trial for 4D-710 in cystic fibrosis. The company has a presence in Ecuador, France, and India. LinkedIn followers grew 24.7% year-over-year.

## Competitive Advantages
- **Proprietary Vector Platform (Therapeutic Vector Evolution)**: The company uses directed evolution to create customized and proprietary AAV vectors (e.g., R100 for retina, A101 for lung) that are optimized for specific tissues and routes of administration, which is a significant differentiator from standard gene therapy approaches.
- **Large-Market Focus**: Unlike many gene therapy companies targeting ultra-rare diseases, 4DMT is focused on large-market indications (wet AMD, DME, cystic fibrosis) with high unmet need, offering a potentially massive commercial opportunity.
- **Durable, Single-Dose Therapies**: Their products are designed to provide multi-year efficacy from a single injection, which could dramatically reduce treatment burden for patients compared to current standard-of-care (e.g., frequent eye injections for wet AMD).

## Strategic Focus
- **Advancing Late-Stage Pipeline**: The primary focus is executing the Phase 3 programs for 4D-150 in wet AMD and progressing 4D-710 in cystic fibrosis.
- **Expanding Indications**: The company is exploring 4D-150 for diabetic macular edema (DME) and seeking partnerships to advance 4D-175 (geographic atrophy) and 4D-725 (A1AT deficiency).
- **Platform Expansion**: Continuing to leverage the Therapeutic Vector Evolution platform to develop new genetic medicines for other large-market diseases.

## Why Work Here
- **Mission-Driven Culture**: The company is deeply committed to "daring to cure" and unlocking the potential of genetic medicine for patients with devastating diseases. Core values include "Dare to Cure," "Break Boundaries," "Prepare & Execute Relentlessly," and "Beyond Yourself."
- **Innovative Science**: Employees work on cutting-edge science at the intersection of gene therapy, vector engineering, and clinical development, tackling some of the biggest challenges in medicine.
- **Collaborative Environment**: The company emphasizes teamwork, internal and external collaboration, and a culture that empowers innovation.
- **Location & Perks**: Based in Emeryville, CA (San Francisco Bay Area). The company offers a competitive benefits package and a dynamic, collaborative environment.
- **Diversity & Inclusion**: 4DMT champions diversity, equity, and inclusion through an employee-led initiative called "4Diversity," which partners with charitable organizations and focuses on social equity.
- **Work Authorization**: Candidates must be authorized to work in the U.S. The company does not sponsor new nonimmigrant visa status petitions but welcomes candidates who require transfers or extensions.

## Sources
1. [4dmoleculartherapeutics.com](https://4dmoleculartherapeutics.com/)
2. [4dmoleculartherapeutics.com - About](https://4dmoleculartherapeutics.com/about/)
3. [4dmoleculartherapeutics.com - Careers](https://4dmoleculartherapeutics.com/careers/)
4. [4dmoleculartherapeutics.com - Pipeline](https://4dmoleculartherapeutics.com/pipeline/)
5. [LinkedIn - 4D Molecular Therapeutics](https://www.linkedin.com/company/4d-molecular-therapeutics-llc)

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