Director, Global Clinical Quality
External
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Responsibilities
- Ensures the immediate communication and escalation of serious issues and signals of concern to the project team and mentors the operational team through the development of action plans.
- Oversees the documentation of observations noted during reviews, investigates trends, issues and risks for root cause.
- What we are searching for:
- Bachelor's degree in Life Sciences or related field
- 5-7 years in a lead Operations role at a clinical site/system research facility and 5-7 years of industry experience in a Quality leadership role
- Strong knowledge of ICH-GCP, FDA, ISO, and other global regulatory requirements
- Expert in Risk-Based and Critical to Quality Strategies at the clinical trial level throughout the project lifecycle
- Must demonstrate strong computer skills and be able to embrace new technologies.
- Mastery of Analytical Data Visualization Tools and techniques preferred
- Demonstrated Leadership and mentorship capabilities in leading teams with a proactive, Quality by Design approach to deliverables
- Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
Benefits
Additional Information
Premier Research is looking for a Director, Global Clinical Quality to join our Global Quality team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.
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