Associate Director Quality - Client Dedicated Process & QD Manager

Responsibilities

• Support process design, mapping, and documentation development for the Global Delivery Organization (GDO).
• Ensure adherence to R&D documentation standards, regulatory compliance, and process harmonization.
• Develop and revise process flow diagrams using designated system and notation standards.
• Manage the development, review, and continuous improvement of Quality Documents, including Controlled Documents (CDs) and Managed Information (MIs).
• Coordinate training assignments and maintain the training matrix for the GDO.
• Support the preparation, coordination, and response for audits and inspections.

Requirements

• Advanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or equivalent.
• Minimum 12 years of experience in clinical development within the pharmaceutical industry or CRO.
• At least 5 years of direct involvement in sponsor-CRO interaction for global trials.
• Deep knowledge of ICH, Good Clinical Practice (GCP), SOPs, and quality management processes.
• Proven leadership and line management skills, including experience leading cross-functional virtual international teams.
• Strong organizational, communication, and problem-solving skills.
• Proficiency in Microsoft Office applications.
• Ability to travel within the region/country.

Preferred Qualifications

• Experience in document management.
• Experience with iGrafx or other process design tools.
• Experience providing support for GCP audits and inspections.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.