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Role Objectives:
As one of the first Quality & Compliance Leads to join the Bengaluru GCM,this role will establishand operationalize quality control execution and maintenancecapabilities for Evidence Generation, including execution of QC processes,following checklists, risk register standards, and archival workflows before scalingto fullsteady-statedelivery
Execute independent quality control reviews of evidence deliverables,maintainthe enterprise evidence generation risk register, and maintain QC evidence andaudit records, enabling the Global Evidence Generation and Quality teams tofocus on scientific judgment, exception decisions, and non-standard qualitydeterminations
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 conventionsincoordinationwith the Global Evidence Generation and Quality teams
Identifyand 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 usingappropriate QCchecklists 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 needed
Confirm QC completion and file QC evidence in theappropriate libraryfor audit readiness and traceability
Escalate scientific, methodological, or complianceconcerns tothe Global Evidence Generation or Quality team per defined escalation protocols
Risk Monitoring & Exception Management
Identify, receive, and log risks, exceptions, or issues arising from study, evidence, quality, or governance processes in the central risk register
Assess and triage each risk or exception by type, impact, ownership, and escalation path; route quality, compliance, or governance exceptions to the US team through theappropriate channels
Track mitigation actions, dependencies, and overdue items; follow up with relevant owners to ensuretimely resolution
Close risks or exceptions once mitigation evidence is confirmed as complete; report recurring themes and patterns to the Global Evidence Generation or Quality team for governance review
QC Evidence & Risk Register Maintenance
Upload QC evidence and risk register artifacts to the designated repository, applying naming conventions, tagging, access controls, and version history in line with defined standards
Link stored QC evidence to the relevant study, deliverable, CAPA, or risk record; flag missing or incomplete records for resolution
Qualifications
Experience: >2 years of related work experience; >2 years of experience in the biopharmaceutical industry; experience in quality control,evidence operations, regulatory submissions, or a related compliance or documentation role at a pharmaceutical company, CRO, or HEORorganization preferred
Technical skills:
Working knowledge of QC review processes for evidence deliverables
Familiarity with risk register management, exception tracking, and mitigation documentation in a regulated pharmaceutical or evidencegeneration environment
Experience managing document repositories including metadata tagging, naming conventions, access controls, etc.
Familiarity with evidence or quality repository platforms and document lifecycle governance
Attention to detail with the ability to apply structured QC checklists accurately and consistently across high volumes
Comfort working with AI-enabled or automated QC tools where rules and templates are defined
Education: A scientific, medical, life sciences, or health economics degree is required
Languages: Fluent Englishrequired;additionallanguages advantageous
Benefits
It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:
Competitive Salary + Performance Annual Bonus
About ICC in Takeda
IND - Bengaluru
Employee
Regular
Full time
IND - Bengaluru - Research and Development
Employee
Regular
Full time
Full time
IND - Bengaluru
Employee
Regular
Full time
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