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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.
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
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 requiredfields
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
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
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.
Experience managing document repositories including metadata tagging, naming conventions, access controls, etc.
Education: A scientific, medical, life sciences, or health economics degree is required
Languages: Fluent English required; additional languages 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
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Flexible work environment, including hybrid working
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Comprehensive Healthcare Insurance Plans for self, spouse, and children
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Group Term Life Insurance and Group Accident Insurance programs
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Health & Wellness programs including annual health screening, weekly health sessions for employees.
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Employee Assistance Program
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5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
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Broad Variety of learning platforms
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Diversity, Equity, and Inclusion Programs
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No Meeting Days
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Reimbursements – Home Internet & Mobile Phone
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Employee Referral Program
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Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)
About ICC in Takeda
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Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.
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As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.
IND - Bengaluru
Employee
Regular
Full time
IND - Bengaluru - Research and Development
Employee
Regular
Full time
IND - Bengaluru - Research and Development
Employee
Regular
Full time
