Overview
Clinical Quality Auditor Jobs in California, United States at Astrix
Title: Clinical Quality Auditor
Company: Astrix
Location: California, United States
Our client, a clinical stage Biotechnology company, focusing on developing immunotherapy-based treatments for cancer and infectious diseases is looking for a Clinical Quality Auditor to join their team!
Position Summary:
The Clinical Quality Auditor is a key contributor to maintaining high standards of GCP compliance throughout clinical trial activities. This role ensures alignment with internal SOPs, ICH guidelines, and FDA regulations, while fostering a culture of continuous inspection readiness. The auditor collaborates across departments—including Clinical Operations, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Data Management—to support a strong GCP Quality Management System and ensure full compliance with applicable regulatory requirements.
Location: Remote with travel requirements (may be required approximately 25%–30% of the time)
Job type: Direct-hire
Salary: $100k- $150k DOE
Key Responsibilities
Maintain and continuously improve the Clinical Trial Quality Management System in alignment with evolving industry standards, regulatory guidance, and best practices.
Participate in the development and review of controlled documents such as SOPs, templates, forms, and work instructions.
Monitor and ensure compliance with internal SOPs and ICH GCP E6 (R2) requirements.
Lead the incident management process by tracking and managing deviations, complaints, and CAPAs.
Coordinate, schedule, and conduct audits across a variety of settings including internal operations, vendors/suppliers, clinical sites, and for-cause audits.
Verify audit findings and manage follow-up activities to confirm satisfactory resolution of compliance issues.
Review essential clinical documents such as protocols, amendments, informed consent forms (ICFs), pharmacy manuals, and clinical study reports (CSRs).
Collaborate with QA, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to address and resolve compliance issues.
Support the creation and delivery of training programs related to GCP regulations, company procedures, and documentation practices.
Maintain accurate and up-to-date records of quality-related activities, including tracking systems for CAPAs, audit findings, deviations, and complaints.
Lead ongoing efforts to ensure readiness for audits and regulatory inspections.
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or a related field, with a minimum of 7 years of GCP experience in biology or pharmaceutical setting; or a Master’s degree in Life Sciences or Engineering with at least 4 years of relevant GCP experience.
Certification as a Quality Auditor (CQA) or similar audit credential is preferred.
Experience with Trial Master File (TMF) systems or electronic document management platforms is a plus.
Strong organizational skills with the ability to prioritize and manage multiple tasks effectively.
In-depth understanding and practical application of ICH GCP E6 (R2) standards.
Ability to multitask and collaborate across departments in a fast-paced environment.
Adaptable and deadline-oriented, with flexibility to meet the dynamic needs of a clinical-stage biotech organization.
*This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! *
