Global Clinical Quality Lead - FSP

IQVIA Inc; Ciudad de México; A distancia; MXN 2.071.000 - 2.636.000; Jornada completa

Descripción de la vacante

IQVIA Inc is seeking an experienced Quality Management professional to lead global quality initiatives across designated units. The role focuses on implementing the Quality Management Plan, ensuring GCP compliance, and aligning with regulatory requirements for clinical development projects.

The ideal candidate will bring 8+ years in clinical trial processes, a strong regulatory background, and proven collaboration with CROs and pharmaceutical partners to improve patient safety and data integrity.

Formación

• 8+ years of experience in clinical trial design, planning, startup, conduct, and reporting.
• Knowledge of national and international regulations and drug development processes.
• Experience with CRO or pharmaceutical industry operations.
• Excellent problem solving skills.
• Ability to establish and maintain effective working relationships with colleagues, managers and clients.
• Fluent in English.

Responsabilidades

• Adopt and implement the global Quality Management Plan within the scope of the assignment.
• Plan and execute Quality Management activities, including risk identification and assessment.
• Support risk mitigation and planning of corrective/preventive actions.
• Assist staff to enhance effectiveness and cooperate with stakeholders.
• Develop and implement aDelivery Unit/Sponsor-specific Quality Management plan and Risk Management Program.
• Provide guidance on GCP compliance to teams.
• Work with teams to manage non-compliance and quality issues per SOPs.
• Inform Quality Management and stakeholders of quality issues per SOPs.
• Assist during audits and regulatory inspections as required by SOPs.
• Act as primary contact for Quality Assurance for the assignment.
• Prepare periodic reports on quality, risk, and improvement initiatives.

Conocimientos

Quality management

Regulatory knowledge

GCP compliance

Clinical trial design

Risk assessment

English fluency

Educación

Bachelor's degree in Life Sciences

Descripción del empleo

IQVIA Inc is seeking an experienced Quality Management professional to lead global quality initiatives across designated units. The role focuses on implementing the Quality Management Plan, ensuring GCP compliance, and aligning with regulatory requirements for clinical development projects.

The ideal candidate will bring 8+ years in clinical trial processes, a strong regulatory background, and proven collaboration with CROs and pharmaceutical partners to improve patient safety and data integrity.