Global Operations Quality Manager
Posted 4 hours 47 minutes ago by ICON
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.
We are currently seeking a point of contact for assigned regional quality and compliance questions, working with QA to ensure alignment and consistent messaging based on GCP and regulatory requirements. This position leads collaborations at country and regional level, as assigned. This position leads consultation on continuous improvement of established processes and procedures. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness
What You Will Be Doing:- 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
- Experience in developing or contributing to processes and/or SOPs and/or WIs
- Ability to lead and execute continuous improvement
- Experience in inspection preparation, participation, and follow-up
- Experience with audits and inspections of sponsor/CRO/site/vendor
- Exposure to all phases of clinical trials
- Broad knowledge of Clinical Operations with prior regulatory knowledge desired
- Demonstrated leadership, critical thinking skills, and ability to influence teams driving them to shared consensus
- Strong verbal and written communication skills with ability to effectively communicate with a broad range of stakeholders at all levels to build strong, positive relationships under challenging and evolving landscapes
- Ability to interact with key stakeholders and create and present complex information effectively to promote excellence in quality
- 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 5 years' experience in quality role
- Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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