Clinical FSP Quality Manager – GCP Compliance, Risk & QA

IQVIA; Ciudad de México; Sur place; MXN 900 000 - 1 300 000; Plein temps

Résumé du poste

IQVIA is seeking an experienced Quality Management professional to support global quality activities within designated Delivery Units and sponsors. You will help define and adopt the Quality Plan, drive risk management, and ensure adherence to ICH, GCP, and SOPs across clinical development.

The role requires strong collaboration with cross-functional teams, effective issue resolution, and fluent English. Prior experience in CRO or pharmaceutical operations is expected.

Qualifications

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

Responsabilités

• Adopt and implement the global Quality Management Plan within the assignment scope and execute Quality activities.
• Identify risks through data review and quality control processes and assist in corrective/preventive actions.
• Support teams to enhance project delivery quality and compliance with SOPs and GCP.
• Provide advice on GCP compliance and manage non-compliance situations.
• Assist during audits and regulatory inspections as required.
• Prepare periodic quality reports for the business lines.

Connaissances

Fluent in English

Problem solving

Relationship building

Description du poste

IQVIA is seeking an experienced Quality Management professional to support global quality activities within designated Delivery Units and sponsors. You will help define and adopt the Quality Plan, drive risk management, and ensure adherence to ICH, GCP, and SOPs across clinical development.

The role requires strong collaboration with cross-functional teams, effective issue resolution, and fluent English. Prior experience in CRO or pharmaceutical operations is expected.