Senior Associate – Clinical Operations (Specialist, Global Procedures & Training)
Location: Bangalore, India
Company: Elanco
Department: R&D Quality Systems & Global 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. The role focuses on quality compliance, training management, document control, audit readiness, regulatory support, data analytics, and continuous improvement initiatives. The position works closely with R&D, Regulatory Affairs, and Quality teams to ensure global compliance and operational excellence.
Key Responsibilities
Quality Management System (QMS) Operations
Manage R&D quality system activities independently.
Track quality metrics and compliance indicators.
Monitor document lifecycle and status reporting.
Support implementation of quality processes and procedures.
Ensure adherence to regulatory and company quality standards.
Training Management
Execute Global Quality System training programs.
Ensure "Right Training, Right Employee, Right Time" compliance.
Maintain training records and completion tracking.
Support training assignments through Learning Management Systems (LMS).
Drive continuous learning and compliance initiatives.
Data Analytics & Reporting
Utilize Power BI for compliance monitoring and reporting.
Develop dashboards and compliance reports.
Analyze trends and identify compliance gaps.
Support management with data-driven insights.
Leverage AI-enabled tools to improve operational efficiency.
Document Management
Create and maintain:
Job Aids
SOP Support Documents
Operational Procedures
Training Materials
Ensure document accuracy and version control.
Maintain document compliance within Veeva Vault.
Audit & Inspection Support
Support regulatory inspections and internal audits.
Maintain inspection-ready documentation.
Provide compliance reports and supporting evidence.
Assist in audit observations and corrective action follow-up.
System Administration
Act as key user for:
Veeva Quality Vault
SuccessFactors
MS Word
Adobe Acrobat
Support system users and troubleshoot process-related issues.
Ensure accurate system documentation and workflows.
Cross-Functional Collaboration
Collaborate with:
R&D Teams
Regulatory Affairs
Quality Teams
Global Stakeholders
Coordinate activities across functions and geographies.
Align deliverables with business and compliance objectives.
Continuous Improvement
Identify process improvement opportunities.
Implement operational excellence initiatives.
Support new system implementations and process changes.
Promote quality culture and compliance mindset.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Biochemistry
Microbiology
Business Administration
Related Scientific Discipline
Experience
2+ years of experience in:
Quality Systems
Document Management
Clinical Operations
Regulatory Environment
Compliance Management
Experience in regulated pharmaceutical, biotech, CRO, or life sciences environment preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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