Associate Director, Therapeutic Area Quality Lead

About the role

Play a pivotal role in driving quality excellence across global clinical research programs, ensuring regulatory compliance and supporting successful delivery of clinical trials.

Key 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, identify and mitigate quality risks, and support audit and inspection readiness.
• Oversee CAPA development, implementation, and effectiveness reviews.

Required profile

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or related field.
• Minimum 7 years of experience in Quality Assurance, Clinical Research, or a 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.

Required skills

• Ability to assess quality risks and manage complex quality issues.
• Experience supporting audits, inspections, CAPAs, and quality governance activities.
• Excellent communication, stakeholder management, analytical, and leadership skills.
• Advanced proficiency in written and verbal English.