Associate Director – Therapeutic Area Quality Lead

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🔥 2 minutes ago

🌐 Argentina, Mexico, +1 more countries – Remote

🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote 🇨🇴 Colombia – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• 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 • Collaborate with global teams across multiple time zones

🎯 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 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

🏖️ Benefits

• Travel domestically and internationally up to 15% as needed • Remote work arrangement