Associate Director, Therapeutic Area Quality Lead – Argentina/Mexico/Colombia

• 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
• Collaborate with global teams across multiple time zones

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or a related field
• Minimum of 7 years of experience in Quality Assurance, Clinical Research, or another 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 effectively 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
• Willingness to travel domestically and internationally up to 15% as needed

• Equal employment opportunities
• Diverse and inclusive work environment
• Collaboration and creativity-focused culture
• Remote work arrangement
• Opportunity to contribute to clinical research advancing patient outcomes