Associate Director – Therapeutic Area Quality Lead

Worldwide Clinical Trials

. Provide strategic Quality Assurance oversight across assigned therapeutic areas and sponsor portfolios .

Posted 10/6/2026full-timeRemote • Argentina, Mexico, ColombiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance within GCP-regulated environments, with a strong focus on ICH-GCP and global regulatory compliance. Proven ability to lead quality governance, manage quality risks, and drive continuous improvement across clinical research programs.

Highest-signal resume keywords

Quality AssuranceICH-GCP KnowledgeRegulatory ComplianceCAPA DevelopmentStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Metrics AnalysisRisk AssessmentAudit SupportInspection ReadinessQuality Governance

Soft Skills

LeadershipCommunicationAnalytical Skills

Industry Keywords

Clinical ResearchCROPharmaceuticalBiotechnologyLife Sciences

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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