Clinical Quality Compliance Specialist

Pharmaceutical Research Associates, Inc; México; Presencial; MXN 600,000 - 800,000; Jornada completa

Descripción de la vacante

Join a leading clinical research organization as a Clinical Quality Compliance Lead. You will ensure quality in clinical trials, manage compliance with regulations, and support training and stakeholder engagement. This role emphasizes collaboration and quality management in a diverse and inclusive environment.

Servicios

Annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Flexible benefits

Formación

• 5 years’ experience in pharmaceutical or bio-pharmaceutical settings.
• 3 years’ experience in a quality role.

Responsabilidades

• Develop and support GCP Lessons Learned and trending analyses.
• Provide training for new processes and guidance.
• Facilitate stakeholder engagement for consensus.

Conocimientos

Quality Management

Risk Management

Regulatory Compliance

Collaboration

Educación

Bachelor’s degree in Science or Quality Management

Descripción del empleo

Overview

As a Clinical Quality Compliance Lead, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Under the leadership of the Operations Quality Lead, develop, contribute to, and support the facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analyses.
• Provide training or awareness for new or established processes or guidance.
• Collaborate with the Operations Quality Lead and the Operations Quality Manager to provide consultation and support for ad hoc requests.
• Stay current with clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for clinical trial management.
• 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.
• Serve as the point of contact for operational quality consultation for assigned clinical trials or assets, escalating to QA as needed.
• Provide risk management, consultation, assessment, and recommendations for escalation regarding potential quality issues or trends.

Qualifications

You are:

• Bachelor’s degree or equivalent with a focus on science or quality management.
• Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization setting, or equivalent.
• Minimum of 3 years’ experience in a quality role.
• Working knowledge of ICH GCP and other relevant regulatory/health authority requirements.
• Knowledge of Quality Management methods, systems, and procedures.
• Experience managing quality within Study Teams for large, complex multinational clinical trials.
• Experience handling operational challenges, risk, and issue management, and assessing non-compliance against study documents, procedures, ICH GCP, and regulations.

What ICON can offer you: Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme, TELUS Health, providing 24/7 support from over 80,000 professionals
• Life assurance
• Flexible, country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion, and belonging are core to our culture. We are committed to providing an inclusive, accessible environment for all candidates. If you require reasonable accommodations during the application process or in performing job functions, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply regardless — you might be exactly what we’re looking for!