[Hiring] Associate Director, Therapeutic Area Quality Lead @Worldwide Clinical Trials

Role Description

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.

As a trusted quality partner, you will work closely with operational leaders, project teams, and sponsor quality counterparts to strengthen quality oversight, promote continuous improvement, and support inspection readiness across assigned therapeutic areas and sponsor portfolios.

Your expertise will help foster a culture of quality, enabling teams to identify risks early, resolve complex issues effectively, and maintain high standards throughout the clinical trial lifecycle.

Qualifications

• 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 environment.
• 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.

Requirements

• 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 compliance.
• Lead quality governance activities and facilitate effective quality decision-making.
• Identify, assess, and mitigate quality risks that may impact clinical research programs.
• Analyze quality metrics and trends to drive proactive improvements and enhance quality outcomes.
• Support audits, regulatory inspections, and inspection-readiness activities.
• Oversee and contribute to CAPA development, implementation, and effectiveness reviews.
• Promote consistent application of quality standards and global regulatory requirements throughout the clinical trial lifecycle.
• Champion a culture of continuous improvement across cross-functional teams.

Benefits

• Remote role open to candidates based in Argentina, Mexico, or Colombia.
• Travel domestically and internationally up to 15% as needed.