I.T. Solutions, Inc.

Compensation

Full Description

Role: QA Auditor, Clinical Supply and Distribution Location: Remote but prefer candidates in Philadelphia or greater Chicago area as most CMO's are there and will need to be on site on the audit dates Type: Contract Position Summary: We are seeking an experienced Oncology QA Auditor with a strong background in clinical quality assurance and a solid understanding of clinical supply kitting and distribution used in clinical trials. Key Responsibilities: • Plan, conduct, and report GCP audits across oncology clinical trials, vendors, and internal systems, with a focus on clinical kitting and distribution • Evaluate the validation, data integrity, and compliance in unblinded oncology studies handling temperature excursions and labeling according to GxP, FDA, EMA, and ICH guidelines. • Perform risk assessments, including algorithm lifecycle oversight, data provenance, audit trails, and system interoperability. • Collaborate with cross-functional teams to review AI model development and deployment strategies. • Support CAPA development and track resolution of findings related to clinical kitting and distribution • Maintain up-to-date knowledge of evolving AI regulatory landscapes (e.g., FDA AI/ML Action Plan, EU AI Act) and quality implications for oncology drug development. Qualifications: • Bachelor’s or Master’s degree in Life Sciences, Computer Science, Engineering, or related field. • Minimum 5 years of QA auditing experience in a GCP environment, preferably in oncology. • Previous auditing experience of clinical supply kitting and distribution • * In-depth knowledge of FDA, EMA, and ICH regulations related to clinical research and digital systems. • Excellent communication, critical thinking, and cross-functional collaboration skills. • Certifications such as Certified Quality Auditor (CQA) are a plus. Preferred Experience: • Previous involvement in audits of decentralized or AI-supported trials • Experience working in a biotech or mid-size pharma company with an understanding of Oral Solid Dosage manufacturing and blinded studies for future audits • Knowledge of data security, privacy (e.g., HIPAA, GDPR), and ethical AI use in clinical settings.