Sr. QA Computer System Validation Mgr.

BioSpace; United States; On-site; USD 126,000 - 145,000; Full time

Job summary

4DMT is seeking a Sr. QA Computer System Validation Manager to oversee validation and lifecycle management of GxP computer systems across GCP, GMP and GLP environments. This role ensures systems comply with FDA, 21 CFR Part 11, EU Annex 11, and GAMP 5 while supporting audits and inspections.

The position partners with IT and business teams to drive risk-based CSV strategies and maintain lifecycle compliance for clinical, quality, lab, enterprise and manufacturing systems.

Qualifications

• Bachelor’s degree as stated in the qualifications.
• Minimum 5-7 years in biopharmaceutical industry, with exposure to both large and small companies.
• Minimum 4 years experience in QA CSV.
• Strong experience supporting computer systems used in clinical trials through all phases of development.
• Extensive experience supporting 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 regulatory compliance.
• Expertise in 21 CFR Part 11 and EU Annex 11, data integrity, and GAMP 5 concepts.

Responsibilities

• Provide QA oversight to support business and CSV activities throughout the lifecycle of GxP computer systems.
• Quality oversight of GxP computerized systems hosted or managed by external partners, and review CSV deliverables.
• Review CSV deliverables, IT change management requests, and quality records to ensure regulatory compliance.
• Provide day-to-day QA guidance for validation activities and controlled change initiatives.
• Serve as SME in CSV requirements and related regulatory standards.
• Assist in development or refinement of QA/CSV procedures and templates.
• Support audits for qualification and requalification of IT vendors.
• Collaborate across functions to identify improvements and implement enhancements.
• Support inspection readiness and regulatory inspections.
• Other duties as assigned by management.

Skills

GxP CSV

FDA 21 CFR Part 11

ICH Guidelines

Data Integrity

Audit Support

Vendor Management

Risk-based Approach

Education

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

Job description

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 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

• 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