Senior Quality & GCP Compliance Lead

IQVIA Argentina; San Francisco (CA); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA is seeking an experienced Quality Management professional to define and execute a global quality plan in collaboration with Delivery Units, sponsors and business lines. The role focuses on risk-based compliance oversight, CAPA management, and supporting inspections and audits to ensure GCP adherence across sites.

The candidate will drive inspection readiness, implement the Quality Management Plan, and advise teams on quality improvements while coordinating with QA and other stakeholders.

Qualifications

• 9+ years total experience.
• Clinical Operations background plus GCP/compliance experience.
• Strong site oversight and risk management experience.
• Oncology experience preferred.
• Sound working knowledge of SOPs, ICH, GCP, regulatory requirements, and quality processes.
• Knowledge of IQVIA corporate standards and SOPs.
• Excellent problem solving, communication and leadership 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; plan and execute activities, risk assessment, and mitigation.
• Cooperate closely with business and stakeholders to maintain focus on quality in project delivery.
• Contribute to development and implementation of a Delivery Unit/Sponsor Quality Management plan and Risk Management Program.
• Provide advice and support to teams on GCP compliance and SOPs; manage non-compliance and quality issues.
• Inform Quality Management and stakeholders of quality issues according to SOPs.

Skills

Fluent in English

Education

Bachelor's Degree or equivalent

Job description

IQVIA is seeking an experienced Quality Management professional to define and execute a global quality plan in collaboration with Delivery Units, sponsors and business lines. The role focuses on risk-based compliance oversight, CAPA management, and supporting inspections and audits to ensure GCP adherence across sites.

The candidate will drive inspection readiness, implement the Quality Management Plan, and advise teams on quality improvements while coordinating with QA and other stakeholders.