Senior Associate – Clinical Operations (R&D Quality Systems & Global Training)
Location: Bangalore, India
Company: Elanco
Department: Clinical Operations / R&D Quality Systems & Training
Employment Type: Full-Time
Role Summary
The Senior Associate – Clinical Operations is responsible for supporting and executing Elanco’s global R&D Quality Management System (QMS) and training framework to ensure regulatory compliance, operational excellence, and inspection readiness across research and development functions.
The role focuses on quality systems management, training administration, document control, compliance reporting, audit support, data analytics, and stakeholder coordination while leveraging digital tools such as Veeva Vault, SuccessFactors, Power BI, and AI-enabled solutions to improve productivity and compliance visibility.
Key Responsibilities
Quality Management System (QMS) Operations
Manage day-to-day R&D Quality Management System activities.
Track quality documents, compliance records, and training assignments.
Monitor QMS metrics and generate status reports.
Support implementation and maintenance of quality processes across R&D functions.
Training Management & Compliance
Execute and support global R&D training programs.
Ensure delivery of:
Right Training
Right Employee
Right Timing
Monitor training compliance and completion status.
Coordinate onboarding and role-based learning activities.
Maintain training records within SuccessFactors and other training systems.
Document Control & Quality Documentation
Maintain controlled documents within Veeva Quality Vault.
Author and update:
Job Aids
Work Instructions
Operational Procedures
Training Documentation
Ensure documentation remains accurate, compliant, and audit-ready.
Support version control and document lifecycle management.
Data Analytics & Reporting
Develop and maintain compliance dashboards and reports.
Utilize Power BI to:
Visualize Compliance Metrics
Identify Trends
Track Quality Performance
Support management reporting through data-driven insights.
Assist with compliance gap analysis and monitoring.
AI & Digital Productivity Initiatives
Utilize AI-enabled tools to improve productivity and reporting efficiency.
Support implementation of digital solutions within R&D operations.
Leverage technology for workflow optimization and compliance monitoring.
Audit & Inspection Support
Support internal audits and regulatory inspections.
Prepare and provide required documentation during audits.
Maintain inspection readiness across assigned areas.
Assist with compliance observations and follow-up actions.
Cross-Functional Collaboration
Partner with:
Clinical Operations
Quality Assurance
Regulatory Affairs
R&D Teams
Global Stakeholders
Coordinate deliverables and compliance requirements across functions.
Facilitate effective communication among stakeholders.
Operational Excellence & Process Improvement
Identify process gaps and recommend improvements.
Drive continuous improvement initiatives.
Support implementation of new systems, processes, and technologies.
Promote efficiency and quality-focused practices.
System Administration & Support
Serve as a key user for:
Veeva Quality Vault
SuccessFactors
Power BI
MS Office Applications
Adobe Acrobat
Provide user support and guidance as needed.
Ensure data integrity within supported systems.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Business Administration
Related Scientific Discipline
Experience
Minimum 2+ years of experience in:
Quality Systems
Clinical Operations
Document Management
Regulatory Compliance
Regulated Environments
Preferred Experience
Experience supporting:
Clinical Research
R&D Operations
Quality Management Systems
Compliance Programs
Experience in pharmaceutical, biotechnology, CRO, or animal health industries.
Uttar Pradesh :
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