Remote Global Therapeutic Area Quality Lead

Worldwide Clinical Trials; Buenos Aires; Remote; ARS 182,485,000 - 273,727,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate Director, Therapeutic Area Quality Lead to drive quality excellence across global clinical research programs. In this QA leadership role, you will help ensure regulatory compliance, proactively manage risk, and support the delivery of high-quality clinical trials worldwide.

As a trusted partner, you will collaborate with operational leaders, project teams, and sponsor QA to strengthen oversight, promote continuous improvement, and ensure

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum of 7 years of experience in Quality Assurance, Clinical Research, or a similar GCP-regulated environment.
• Strong knowledge of ICH-GCP, FDA, European, UK, and other global regulatory requirements.
• Experience within a CRO, pharmaceutical, biotechnology, or other regulated life sciences organization.
• Proven ability to assess quality risks, manage complex quality issues, and collaborate with Sponsor QA organizations.
• Experience supporting audits, inspections, CAPAs, and quality governance activities.
• Excellent communication, stakeholder management, analytical, and leadership skills.
• Advanced proficiency in English, both written and verbal.

Responsibilities

• Provide strategic Quality Assurance oversight across assigned therapeutic areas and sponsor portfolios.
• Partner with operational leadership, project teams, and sponsor quality counterparts to strengthen quality performance and regulatory compliance.
• Lead quality governance activities and facilitate effective quality decision-making across clinical research programs.
• Identify, assess, and mitigate quality risks to support successful study execution and patient-focused outcomes.
• Analyze quality metrics and trends to drive proactive improvements and enhance quality performance.
• Support audits, regulatory inspections, and inspection-readiness initiatives across assigned areas.
• Oversee CAPA development, implementation, and effectiveness reviews to ensure sustainable quality outcomes.
• Promote the consistent application of quality standards and global regulatory requirements throughout the clinical trial lifecycle.
• Champion a culture of continuous improvement across cross-functional teams.

Skills

Quality Assurance

Clinical Research

Regulatory knowledge

Leadership

Education

Bachelor's degree in Life Sciences or related field

Job description

Worldwide Clinical Trials is seeking an Associate Director, Therapeutic Area Quality Lead to drive quality excellence across global clinical research programs. In this QA leadership role, you will help ensure regulatory compliance, proactively manage risk, and support the delivery of high-quality clinical trials worldwide.

As a trusted partner, you will collaborate with operational leaders, project teams, and sponsor QA to strengthen oversight, promote continuous improvement, and ensure