Job description:
XBiotech USA, Inc. is currently seeking an experienced Clinical Quality Assurance (QA) Specialist to join our team in Austin, TX.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies based on its True Human™ proprietary technology.
Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy, and tolerability.
Position Summary:
The Clinical QA Specialist provides strategic QA oversight across clinical development programs of XBiotech, leverages expertise to ensure clinical research operations comply with regulatory standards (ICH-GCP, FDA, EMA, etc.) and internal policies, focusing on data integrity, patient safety and process improvements.
Key Responsibilities:
Compliance and Oversight:
· Develop and maintain the Quality Management System (QMS) and SOPs, to ensure compliance with Good Clinical Practice (GCP), and Good Laboratory Practices (GLP).
· Review and approve essential clinical trial documentation (protocols, reports, SOPs, etc.) for accuracy and compliance.
· Provide QA oversight for Phase I–III clinical trials, ensuring compliance with protocols, GCP, and applicable regulations throughout the trial lifecycle.
· Evaluate and manage protocol deviations and serious breaches in accordance with regulatory requirements.
· Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and Regulatory Affairs to embed quality throughout clinical development.
CAPA and Risk Management:
· Manage the development, implementation and effectiveness of Corrective and Preventive Actions (CAPA).
· Perform root cause analysis for compliance issues. Conduct risk assessments and implement mitigation strategies.
· Track issues to resolution and trend data for systemic improvements.
· Proactively identify, report and mitigate risks within clinical research processes.
Audit and Inspection Readiness:
· Plan and execute QA audits of clinical trial sites, vendors, CROs, and internal processes.
· Conduct vendor qualification audits and ongoing oversight of third-party providers.
· Review and trend Audit Reports to propose process improvements.
· Prepare for and host regulatory inspections, ensuring all documentation is ready. Review audit findings and ensure timely resolution.
Training:
· Provide training on GCP and quality standards to staff and foster a culture of quality.
QUALIFICATIONS/EXPERIENCE REQUIRED:
· Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Master’s degree preferred.
· 5-7+ years of clinical research experience, including QA experience (3+ years) is required.
· Experience with regulatory inspections (FDA/EMA) preferred.
· Demonstrated experience planning and conducting clinical site and vendor audits, and hosting regulatory audits.
· Demonstrated competencies in GCP and regulatory compliance knowledge
· Proficiency with Electronic Data Capture (EDC) and eTMF systems.
· Excellent written and verbal communication skills.
· Must be a self-motivated and detail-oriented person who works well in a team setting.
· Must be willing to learn and adapt to changes in a fast-paced working environment.
·Must be able to multitask and have strong organizational skills.
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Education:
Experience:
- Clinical research: 5 years (Required)
- QA: 3 years (Required)
Work Location: In person
