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Job Description:

Role Objectives :

As one of the first Quality & Compliance Leads to join the Bengaluru GCM, this role will establish and operationalize quality control execution and maintenance capabilities for Evidence Generation, including execution of QC processes, following checklists, risk register standards, and archival workflows before scaling to full steady-state delivery .

Execute independent quality control reviews of evidence deliverables, maintain the enterprise evidence generation risk register, and maintain QC evidence and audit records, enabling the Global Evidence Generation and Quality teams to focus on scientific judgment, exception decisions, and non-standard quality determinations .

Key Responsibilities :





Initial Capability Build:

In the early build phase, contribute to the adaption of the QC checklist standards, risk register taxonomy, exception triage criteria, escalation thresholds, repository metadata requirements, and archival naming conventions incoordination with the Global Evidence Generation and Quality teams
Identify and flag process gaps, scope boundary ambiguities between GCM and the US organization, and repository readiness issues before they affect audit traceability or compliance

QC Execution on Evidence Deliverables:

Run automated first-pass QC on evidence deliverables using appropriate QC checklists where rules, templates, and escalation thresholds are defined; perform manual QC checks for completeness, formatting, references, and required fields
Log all QC findings, exceptions, and rework items consistently and follow up on deliverables for correction or clarification as need

📌 Evidence Generation Quality and Compliance Lead (Bengaluru)
🏢 Takeda
📍 Bengaluru