IT Validation Contractor (U.S. Remote)

Description

Transforming Cancer Therapy Together

At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives.

Why ADC Therapeutics?

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States, conditional approval from the European Commission and conditional approvals in other countries. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use.

We are a team of approximately 150 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.

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:

Job responsibilities may include, but are not limited to:

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.

Requirements

Who You Are:

• 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 in a small biotech setting with limited internal resource is preferred.
• Experience with cloud-based or SaaS systems and supplier assessments preferred.
• Experience supporting regulatory inspections or audits.

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.

Join Our Inclusive Team:

ADC Therapeutics is an equal opportunity employer. We are committed to building collaborative, engaged teams and fostering a professional and respectful work environment where employees are empowered for success. We consider all qualified applicants without regard to any characteristic protected by law.