Specialist, GCP Quality

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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

RayzeBio is seeking a Specialist of GCP Quality. This role will be responsible for assisting in the coordination and implementation of Good Clinical Practice (GCP) related quality assurance activities for RayzeBio’s Clinical Development team. These responsibilities include supporting the execution and maintenance of the audit program focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and RayzeBio’s policies and procedures.  The Specialist of GCP Quality manages the tracking of audit findings, Corrective and Preventive Actions (CAPAs) and Non-conformances, as needed. Additional responsibilities include supporting RayzeBio inspection readiness plan.  This position will report to the Sr. Manager, GCP Quality and oversee GCP quality functions within RayzeBio.

Key Responsibilities:

• Support and maintain GCP quality management systems, policies, and SOPs

• Monitor, track, and trend GCP non-conformances, deviations, CAPAs

• Support GCP audit activities, internal and external, including conducting clinical vendor qualifications and audits, conduct investigator site audits

• Support and maintain the internal audit program, audit schedule, and approved vendor list. May be involved in the conduct of both internal and external audits. 

• Work closely with clinical study management teams to provide clinical compliance information, help identify issues, support continuous improvement and help identify and mitigate risks.

• May serve as GCP QA Subject Matter Expert (SME) for assigned clinical stage programs, ensuring balance between operational timelines and compliance requirements.  

•  Assist in writing and reviewing operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS)

• Assist in developing reports quality/KPI metrics to support GCP activities and management review

•  Responsible for maintaining current regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the United States of America Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.

• Assist with inspection readiness activities which include operating per the inspection readiness plan, risk mitigation and inspection readiness training.  

• 10% of travel may be required

Education & Experience:

• Bachelor’s degree or higher

• Minimum 5 years in GxP (GMP, GLP, GCP) pharmaceutical environment in progressively responsible Quality roles or 3 years with advanced degree. Highly desirable to have a minimum of 3 years of Quality Systems experience.

• Understanding of US and European regulations including application in the day-to-day environment