Sr. QA Computer System Validation Mgr. Employer 4D Molecular Therapeutics Location Emeryville, California Start date Aug 28, 2026 View more categories View less categories Discipline Quality , Quality Assurance Required Education Bachelors Degree Position Type Full time Hotbed Biotech Bay , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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 Company 4DMT is a gene therapy company with a transformative discovery platform

• Therapeutic Vector Evolution
• -that enables our "disease first" approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

At 4DMT we are creating and developing optimized "biopharmaceutical grade" AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases. While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors . The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration. At 4DMT we use our robust discovery platform, termed "Therapeutic Vector Evolution," to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo . 4

D Purpose Statement:

Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients

GUIDING PRINCIPLES

Dare to Cure

• Patients are waiting. Create big dreams for patients and take calculated risks to achieve them Break Boundaries
• Question the status quo and innovate beyond conventional approaches Beyond Yourself
• It's about patients, their families, our team, our families. We strengthen each other. Prepare and Execute Relentlessly
• Start with the end in mind, over-prepare and make contingency plans to your contingency plans We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults.

We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development.

Company info Website http:

//www.4dmoleculartherapeutics.com/ Phone 510-505-2680 Location 5858 Horton St. Suite 455 Emeryville California 94608 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Director, QA Validation & Computer Systems Assurance Saratoga Springs, New York Manager QA

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