Evidence Generation Quality and Compliance Lead

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

• 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. We’re not just transforming our company; we’re 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.

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Locations

IND - Bengaluru - Research and Development

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Locations

Worker Type

Worker Sub-Type

Time Type

Full time