RayzeBio · 3 hours ago
Specialist, GCP Quality
United States
Full-time
Remote
Mid, Senior Level
$69K/yr - $93K/yr
5+ years exp
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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.
Qualification
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Required
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
Previous experience with regulatory agency inspections
Ability to successfully solve challenging issues, critical thinking, and detail oriented
Strong interpersonal, verbal, and written communication skills
Demonstrable record of strong teamwork in a cross-functional industry environment.
Excellent written and verbal communication skills.
Highly organized, with the ability to multi-task and handle pressure well
Meticulous with detail and precision
Ability to think through a project or task of diverse complexity and execute independently from beginning to end
Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
Strong communication and interpersonal skills
Should be assertive, proactive, professional, and confident
Excellent professional ethics and integrity
Flexibility to adapt in a cross-functional and dynamic environment
Preferred
Previous experience in a start-up company
Benefits
Incentive cash and stock opportunities
Company
RayzeBio
RayzeBio is a pharmaceuticals company that develops targeted radiopharmaceutical drugs for cancer.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$418MKey Investors
Venrock Healthcare Capital Partners
2023-12-26Acquired· by Bristol-Myers Squibb
2023-09-15IPO· nasdaq:RYZB
2022-09-13Series D· $160M
Leadership Team
Deborah Charych
Scientific Founder, Chief Technology Officer, Advisor
Susan Moran
Chief Medical Officer
Recent News
InvestorPlace
2024-05-05
Company data provided by crunchbase
