General CRO seeks an Associate Director of Quality Assurance to lead therapeutic area quality oversight across Latin American operations. The role involves strategic quality governance, regulatory compliance, risk management, and inspection readiness across clinical research programs serving multiple sponsors.
Responsibilities
Provide strategic quality assurance oversight across assigned therapeutic areas and sponsor portfolios
Partner with operational and sponsor teams to strengthen quality performance and regulatory compliance
Lead quality governance activities and facilitate quality decision-making across clinical programs
Identify, assess, and mitigate quality risks throughout study execution
Analyze quality metrics and trends to drive proactive improvements and performance enhancement
Requirements




Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or related field
Minimum 7 years quality assurance or clinical research experience in GCP-regulated environments
Strong knowledge of ICH-GCP, FDA, European, UK, and global regulatory requirements
Experience in CRO, pharmaceutical, biotechnology, or regulated life sciences organizations
Proven ability to assess quality risks and manage complex quality issues
Experience with audits, inspections, CAPAs, and quality governance activities
Advanced English proficiency, written and verbal

📌 Associate Director, Therapeutic Area Quality Lead(Argentina /Mexico / Colombia) (Buenos Aires)
🏢 Worldwide Clinical Trials
📍 Buenos Aires