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 Apply for this job

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Do you have at least 4 years of experience providing QA oversight for Computer System Validation (CSV) within the biopharmaceutical industry?
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IRT/RTSM

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Candidates must be authorized to work in the United States and provide valid work authorization documentation throughout their employment in accordance with U.S. immigration requirements. 4D Molecular Therapeutics welcomes candidates who require nonimmigrant visa transfers or extensions; however, the company does not sponsor new nonimmigrant visa status petitions.

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