Clinical Quality & Compliance Lead

IQVIA Argentina; Plano (TX); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services. This role supports quality control, risk management, and CAPA oversight across designated Delivery Units and sponsors to ensure adherence to ICH, GCP, and SOPs.

As a key GCP expert, you will drive inspection readiness, collaborate with regional teams, and implement the global Quality Management Plan. Oncology experience is preferred, with strong communication and leadership skills essential.

Qualifications

• 9+ years in clinical operations and GCP/compliance related work.
• Strong knowledge of SOPs, ICH, and regulatory requirements.
• Experience with risk management and CAPA processes.
• Oncology exposure is preferred but not mandatory.

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 and related risk activities.
• Collaborate with stakeholders to maintain focus on quality in project delivery.
• Develop unit-specific Quality Management and Risk programs and monitor delivery.
• Provide guidance on GCP compliance to teams and SOP adherence.
• Assist during audits and regulatory inspections as required by SOPs.
• Prepare periodic quality risk reports and improvement initiatives.

Skills

Fluent English

9+ years experience

Clinical Operations background

GCP/compliance experience

Site oversight

Risk management

Oncology experience preferred

Organizational skills

Interpersonal & communication

Judgement & decision-making

Influencing & negotiation

Microsoft Office

Problem solving

Travel ability

Team leadership

Relationship building

Education

Bachelor's Degree or equivalent

Job description

IQVIA is a leading global provider of clinical research services. This role supports quality control, risk management, and CAPA oversight across designated Delivery Units and sponsors to ensure adherence to ICH, GCP, and SOPs.

As a key GCP expert, you will drive inspection readiness, collaborate with regional teams, and implement the global Quality Management Plan. Oncology experience is preferred, with strong communication and leadership skills essential.