Senior QA Lead, Therapeutic Area — Remote

Worldwide; Buenos Aires; Hybrid; ARS 167,234,000 - 212,844,000; Full time

Job summary

Worldwide is seeking an Associate Director, Therapeutic Area Quality Lead to drive quality excellence across global clinical programs. This remote role supports consistency of QA governance, risk management, and regulatory readiness across Argentina, Mexico and Colombia, with up to 15% travel.

You will partner with operational leaders, project teams and Sponsor QA to ensure high-quality trial delivery, lead CAPA programs and promote continuous improvement in a global environment.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum of 7 years in Quality Assurance, clinical research, or a GCP-regulated environment.
• Strong knowledge of ICH-GCP and global regulatory requirements (FDA, EMA, UK, etc.).
• Experience in CRO/pharma or regulated life sciences organizations.
• Proven ability to assess quality risks, manage complex issues, and collaborate with Sponsor QA.
• Excellent communication, stakeholder management, analytical and leadership skills.
• Advanced proficiency in English (written and spoken).

Responsibilities

• Provide strategic QA oversight across therapeutic areas and sponsor portfolios.
• Collaborate with operations, project teams, and Sponsor QA to strengthen quality performance and regulatory compliance.
• Lead quality governance activities and facilitate effective QA decision-making.
• Identify, assess and mitigate quality risks to support study execution and patient outcomes.
• Analyze quality metrics and trends to drive proactive improvements.
• Support audits, regulatory inspections, CAPA development, and inspection readiness.

Skills

Quality Assurance

Clinical Research

GCP & Regulatory

Audits & CAPAs

Stakeholder Management

Leadership

English Proficiency

Education

Bachelor's degree in Life Sciences

Job description

Worldwide is seeking an Associate Director, Therapeutic Area Quality Lead to drive quality excellence across global clinical programs. This remote role supports consistency of QA governance, risk management, and regulatory readiness across Argentina, Mexico and Colombia, with up to 15% travel.

You will partner with operational leaders, project teams and Sponsor QA to ensure high-quality trial delivery, lead CAPA programs and promote continuous improvement in a global environment.