Clinical Quality Compliance Specialist (México)

Clinical Quality Compliance Specialist (México)

07 ago
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México

07 ago

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México

As a Clincial Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**What you will be doing**:
- 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
- In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests
- Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials
- Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus
- Develop matrix relationships to involve process experts and conduct improvement activities
- 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.
**You are**:
- 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
**What ICON can offer you**:
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 maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a general network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

📌 Clinical Quality Compliance Specialist (México)
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📍 México

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