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

This is a fully remote position, open to applicants in Argentina, +2 more countries.

📋 Description

• Provide strategic oversight in Quality Assurance across designated therapeutic areas and sponsor portfolios.

• Collaborate with operational leadership, project teams, and sponsor quality counterparts to enhance quality performance and ensure regulatory compliance.

• Lead governance activities related to quality and facilitate effective decision-making regarding quality across clinical research programs.

• Identify, evaluate, and mitigate quality risks to facilitate successful study execution and outcomes that focus on patients.

• Analyze quality metrics and trends to promote proactive enhancements and elevate quality performance.

• Support audits, regulatory inspections, and initiatives that prepare for inspections across assigned areas.

• Oversee the development, implementation, and effectiveness review of CAPA to ensure sustainable quality outcomes.

• Advocate for the consistent application of quality standards and global regulatory requirements throughout the clinical trial lifecycle.

• Foster a culture of continuous improvement across cross-functional teams.

• Collaborate with global teams spanning multiple time zones.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or a related discipline.

• At least 7 years of experience in Quality Assurance, Clinical Research, or a GCP-regulated environment.

• Strong understanding of ICH-GCP, FDA, European, UK, and other international regulatory standards.

• Experience in a CRO, pharmaceutical, biotechnology, or another regulated life sciences organization.

• Demonstrated capability to assess quality risks, manage complex quality challenges, and collaborate effectively with Sponsor QA organizations.

• Experience in supporting audits, inspections, CAPAs, and activities related to quality governance.

• Exceptional communication, stakeholder management, analytical, and leadership abilities.

• Advanced proficiency in English, both written and spoken.

• Willingness to travel domestically and internationally up to 15% as required.

🏝️ Benefits

• Equal employment opportunities.

• Diverse and inclusive work environment.

• A culture that emphasizes collaboration and creativity.

• Remote work arrangement available.

• Opportunity to make a meaningful contribution to clinical research that advances patient outcomes.