Operations Quality Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

As a Operations Quality Specialist at ICON, you will ensure the highest standards of quality and compliance in our drug development processes.

What You Will Do:

This position supports the development and implementation of initiatives and
established processes that support operations in maintaining inspection readiness. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness

Key responsibilities include:

• Creates process and tools to achieve inspection readiness within Development Operations

• Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis

• Provide training or awareness for new or established processes or guidance

• Become thoroughly familiar with assigned compounds and protocols

• Support overall quality within assigned clinical trials and submissions

• For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed

• Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends

• Provide training and coaching to promote awareness educating study teams towards quality deliverables

• Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables
   

Your Profile:

You will have a strong foundation in quality assurance and compliance, with the experience to work independently and guide others.

Required qualifications and experience:

• Bachelor’s degree or equivalent with a strong emphasis on science or quality management 

• Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent 

• Minimum of 3 years’ experience in quality role

• Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience

• Working knowledge of Quality Management methods, systems, and relevant procedures

• Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials  

• Experience in managing complex and sensitive operational challenges

• Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements

• Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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