Operations Quality Specialist
Job Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply