Evidence Generation Quality and Compliance Lead

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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 :

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 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 requiredfields  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 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 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

Flexible work environment, including hybrid workingComprehensive Healthcare Insurance Plans for self, spouse, and childrenGroup Term Life Insurance and Group Accident Insurance programsHealth & Wellness programs including annual health screening, weekly health sessions for employees.Employee Assistance Program5 days of leave every year for Voluntary Service in addition to Humanitarian LeavesBroad Variety of learning platforms Diversity, Equity, and Inclusion ProgramsNo Meeting DaysReimbursements – Home Internet & Mobile PhoneEmployee Referral ProgramLeaves – 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:

IND - Bengaluru - Research and Development

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Locations:

IND - Bengaluru

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time