Associate Director, Therapeutic Area Quality Lead(Argentina /Mexico / Colombia)

Play a pivotal role in driving quality excellence across global clinical research programs. In this strategic Quality Assurance leadership role, you'll help ensure regulatory compliance, proactively manage quality risks, and support the successful delivery of clinical trials that advance patient outcomes worldwide. This is a remote role open to candidates based in Argentina, Mexico, or Colombia. You will collaborate with global teams across multiple time zones. Travel domestically and internationally up to 15% as needed.

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

Requirements

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