QA Auditor, Clinical Supply and Distribution

QA Auditor, Clinical Supply and Distribution Location: Remote/Philadelphia, PA or Chicago, IL Need to be on site on the audit dates 6 months Contract
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 Google Cloud Platform 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 Google Cloud Platform 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 understanding of Oral Solid Dosage manufacturing and blinded studies for future audits
• Understanding of data security, privacy (e.g., HIPAA, GDPR), and ethical AI use in clinical settings.

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.