Designation : Manager

Function : DQA

Functional Area : Developmental QA - Clinical Studies

Job Role Summary : Manager, Development Quality Assurance (Inspection Readiness) within the Global Development Organization (GDO) is responsible for establishing, maintaining, and advancing global regulatory inspection preparedness. The Manager/Sr Manager will act as a strategic partner to Clinical Development and Operations, Quality, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external partners to instill inspection preparedness into routine operations and foster a culture of inspection excellence.

Job Profile

• Design, implement, and maintain a global clinical inspection preparedness framework across GDO asset programs in collaboration with cross‑functional stakeholders.
• Partner with the VP and Head of Development QA to define inspection readiness KPIs and contribute to governance reporting, dashboards, and risk monitoring activities.
• Drive ongoing preparedness activities, including mock inspections, gap assessments, and targeted readiness health checks.




• Embed inspection preparedness throughout the clinical trial lifecycle, including start‑up, conduct, and close‑out phases.
• Serve as the primary inspection readiness lead for Health Authority inspections at the Princeton, NJ site and partnering closely with regional inspection teams at global facilities.
• Oversee inspection preparation, execution, and follow‑up activities, including document readiness, inspection logistics, and SME preparation and coaching.
• Lead inspection response activities, including daily debriefs, Health Authority interactions, post‑inspection commitments, and CAPA development and tracking.
• Identify systemic inspection risks and lead mitigation, remediation, and continuous improvement initiatives.
• Ensure timely and effective completion of inspection‑related CAPAs and audit actions, monitoring effectiveness and sustainability.
• Communicate inspection risk, c

📌 Manager – Development Quality Assurance (Gurugram)
🏢 Qvents.In
📍 Gurugram