We are currently seeking an Executive - QA (Bioanalytical) to join our Clinical Research team. The role will support the delivery of robust regulatory compliance oversight, data review and integrity, quality systems management, as well as documentation and reporting activities.

The role will include the following:

• QMS deployment, verification, and reporting through systematic audits
• Project/study-specific analytical review as a primary responsibility
• Support the clinical quality team in quality assurance activities as required
• Verify and ensure that the studies are conducted as per ICH-GCP, regulatory requirements, and protocol
• Ensure preparedness and hosting of external audits and inspections, and timely follow-up and closure of audit observations
• Support organization-wide Quality initiatives
• Support in providing required metrics for quality measurement
• Controlled procedural documents custody and maintenance of SOP master lists
• Quality Assurance audit of BA/BE Bioanalytical and support clinical QA
• Facilitate and perform system audits
• Audit reports management - preparation, communication, and closure
• Quality issue follow-up, identification, and escalation.
• CAPA effectiveness checks as necessitated for identified findings
• Support and manage organization-wide quality initiatives, specifically ISO 9001 and ISO 27001

• 2 – 4 years of Bioanalytical QA experience
• Deep understanding of FDA, EMA, ICH, and GLP guidelines
• Familiarity with audit processes and regulatory inspections
• Knowledge of method development and validation protocols