Evidence Generation Quality and Compliance Lead

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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: I nitial 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 needed ​ Confirm QC completion and file QC evidence in the appropriate library for audit readiness and traceability ​ Escalate scientific, methodological, or compliance concerns to the 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 the appropriate channels ​ Track mitigation actions, dependencies, and overdue items; follow up with relevant owners to ensure timely 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 HEOR organization 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 evidence generation 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 ​ <