Evidence Generation Quality and Compliance Lead

Role Objectives:

As one of the first Quality & Compliance Leads to join the Bengaluru GCMthis role will establishand operationalize quality control execution and maintenancecapabilities for Evidence Generation including execution of QC processesfollowing checklists risk register standards and archival workflows before scalingto fullsteady-statedelivery.

Execute independent quality control reviews of evidence deliverablesmaintainthe 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 taxonomyexception triage criteria escalation thresholds repository metadata requirements and archival namingconventionsincoordinationwith the Global Evidence Generation and Quality teams

• Identifyand flag process gaps scope boundary ambiguities between GCM and the US organization andrepository 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 templatesand escalation thresholds are defined; perform manual QC checks for completeness formatting references andrequired fields

• Log all QC findings exceptions and rework items consistently and follow up on deliverables for correction orclarification 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 teamper defined escalation protocols

Risk Monitoring & Exception Management

• Identify receive and log risks exceptions or issues arising from study evidence quality or governanceprocesses in the central risk register

• Assess and triage each risk or exception by type impact ownership and escalation path; route qualitycompliance or governance exceptions to the US team through theappropriate channels

• Track mitigation actions dependencies and overdue items; follow up with relevant owners to ensuretimelyresolution

• Close risks or exceptions once mitigation evidence is confirmed as complete; report recurring themes andpatterns 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 conventionstagging 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 incompleterecords for resolution

Qualifications:

Experience:>2 years of related work experience; >2 years of experience in the biopharmaceutical industry; experience in quality controlevidence 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 English;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

• Flexible work environment including hybrid working
• Comprehensive Healthcare Insurance Plans for self spouse and children
• Group Term Life Insurance and Group Accident Insurance programs
• Health & Wellness programs including annual health screening weekly health sessions for employees.
• Employee Assistance Program
• 5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
• Broad Variety of learning platforms
• Diversity Equity and Inclusion Programs
• No Meeting Days
• Reimbursements Home Internet & Mobile Phone
• Employee Referral Program
• Leaves Paternity Leave (4 Weeks) Maternity Leave (up to 26 weeks) Bereavement Leave (5 days)

About ICC in Takeda

• Takeda is leading a digital revolution. Were not just transforming our company; were improving the lives of millions of patients who rely on our medicines every day.
• 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

Full time