Clinical Quality & Compliance Lead

IQVIA Argentina; California (MO); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA Argentina seeks a senior Quality professional to guide global GCP compliance, risk management, and quality program delivery. You will oversee country/site level activities, support inspections, and drive corrective/preventive actions to ensure regulatory alignment and patient safety.

The role emphasizes cross-functional collaboration, strategic quality planning, and effective communication with stakeholders across regions, with travel as needed.

Qualifications

• 9+ years total experience.
• Clinical Operations background plus GCP/compliance experience.
• Strong site oversight and risk management experience.
• Oncology experience preferred.
• Knowledge of ICH, GCP, SOPs and regulatory requirements.
• Good organizational, interpersonal and communication skills.

Responsibilities

• Conduct country and site-level compliance oversight using a risk-based approach.
• Identify compliance risks, conduct site assessments, and manage CAPAs.
• Support inspections and audits while serving as the local GCP expert.
• Drive inspection readiness and compliance at the country level.
• Adopt and implement the global Quality Management Plan within the scope of the assignment.
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program.
• Provide advice and support to teams on all aspects of GCP compliance.
• Work with teams to manage non-compliance and quality issues; plan CAPAs as needed.
• Inform Quality Management and QA of quality issues per SOPs.
• Work with QA during audits and regulatory inspections as required.
• Act as primary contact for Quality Assurance and attend meetings.
• Prepare periodic reports to business lines on quality related matters and risk assessments.

Skills

Fluent in English

Communication skills

Negotiation skills

Microsoft Office

Problem solving

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

IQVIA Argentina seeks a senior Quality professional to guide global GCP compliance, risk management, and quality program delivery. You will oversee country/site level activities, support inspections, and drive corrective/preventive actions to ensure regulatory alignment and patient safety.

The role emphasizes cross-functional collaboration, strategic quality planning, and effective communication with stakeholders across regions, with travel as needed.