IT Validation Contractor (U.S. Remote)
ADC Therapeutics
Summary
The IT Validation role is a part-time contractor, estimated at approximately 10-20 hours per week based on project phase, and reports to the Executive Director, Global Clinical Quality Assurance. The role provides quality oversight of computerized system validation (CSV) activities for GCP, PV, and GLP-regulated systems. Validation execution is performed by external vendors and contractors, while this contractor ensures that work is planned, documented, and completed in line with regulatory requirements and company procedures.
Job description
Job Summary
The IT Validation role is a part-time contractor, estimated at approximately 10-20 hours per week based on project phase, and reports to the Executive Director, Global Clinical Quality Assurance. The role provides quality oversight of computerized system validation (CSV) activities for GCP, PV, and GLP-regulated systems. Validation execution is performed by external vendors and contractors, while this contractor ensures that work is planned, documented, and completed in line with regulatory requirements and company procedures.
The contractor serves as the Quality point of contact for validation, reviews and approves key deliverables, and confirms each system is fit for intended use and inspection ready.
What You'll Do
Vendor and contractor oversight
- Provide Quality oversight of vendors and contractors performing validation activities.
- Support vendor selection and qualification, including review of vendor quality systems and capabilities.
- Monitor vendor progress against agreed timelines, scope, and deliverables; escalate risks or delays.
- Ensure vendors follow appropriate SOPs, agreements and applicable regulatory requirements.
Validation oversight
- Review and approve validation deliverables, such as the Validation Plan, User Requirements, Risk Assessment, IQ/OQ/PQ protocols, test scripts, traceability matrix, and Validation Summary Report.
- Confirm a risk-based validation approach consistent with GAMP 5 principles.
- Verify that test deviations and defects are documented, assessed, and resolved before release.
- Confirm that systems meet requirements for audit trails, electronic records, and electronic signatures (21 CFR Part 11 and EU Annex 11).
Quality and compliance
- Act as the Quality point of contact for validation of GCP, PV, and GLP-related systems.
- Support change control, periodic review, and data integrity (ALCOA+) for validated systems.
- Help draft or update SOPs and templates related to computerized system validation, as needed.
- Support audits and regulatory inspections by ensuring validation documentation is complete and retrievable.
- Provide regular status updates to the Executive Director, Global Clinical Quality Assurance.
- Collaborate with GMP quality and CMO quality control, as required
- Other duties, as assigned.
Skills and Competencies
- Strong attention to detail when reviewing validation documentation.
- Clear written and verbal communication with vendors and internal stakeholders.
- Ability to work independently and manage priorities with minimal supervision.
- Practical, risk-based judgment suited to a small organization.
Requirements
- Bachelor's degree in a scientific, technical, or IT-related field, or equivalent experience
- 7+ years of experience in computerized system validation in a regulated pharmaceutical, biotech, or CRO environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH E6(R3) as it applies to computerized systems
- Experience overseeing third-party vendors or contractors performing validation work
- Experience with GCP, PV, and/or GLP systems, for example safety databases, eTMF, EDC, or LIMS
- Experience supporting regulatory inspections or audits
- Strong attention to detail when reviewing validation documentation
- Clear written and verbal communication with vendors and internal stakeholders
- Ability to work independently and manage priorities with minimal supervision
- Practical, risk-based judgment suited to a small organization
Company overview
ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (ADCs), specializing in oncology therapeutics. Founded in 2011 and headquartered in Lausanne, Switzerland with operations in New Jersey, the company focuses on developing highly potent and targeted ADCs for the treatment of hematological cancers and solid tumors. Their flagship product, ZYNLONTA® (loncastuximab tesirine-lpyl), is a CD19-directed ADC that received accelerated FDA approval and conditional European Commission approval for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The company leverages specialized capabilities spanning clinical development, manufacturing, and commercialization, with a proven track record that includes an approved and marketed product. ADC Therapeutics maintains a global team of over 300 employees and operates with a flat organizational structure that encourages collaboration and innovation. Beyond ZYNLONTA, the company is advancing IND-enabling activities for a next-generation PSMA-targeting ADC and exploring combination therapies and earlier lines of treatment. Their mission centers on transforming cancer treatment paradigms through targeted ADC technology and bringing novel therapeutic options to patients worldwide.