Senior Associate – Clinical Operations
Company: Elanco
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: R&D Quality Systems & Global Training
Experience: 2+ Years
About the Role
Elanco is seeking a Senior Associate – Clinical Operations to support global R&D Quality Systems and Training operations. The role involves managing Quality Management Systems (QMS), training compliance, document control, audit support, and data reporting activities while ensuring global regulatory compliance across R&D functions.
Key Responsibilities
Quality Management Systems (QMS)
Manage QMS activities including document tracking, metrics collection, and status reporting.
Support global quality initiatives and regulatory compliance requirements.
Monitor quality system effectiveness and compliance performance.
Training & Compliance
Execute Global Quality System training programs.
Ensure timely assignment and completion of required training.
Maintain training records and compliance documentation.
Data Analytics & Reporting
Utilize Power BI to monitor compliance metrics and identify trends.
Generate dashboards and reports for R&D management.
Support data-driven decision-making and process improvements.
Documentation & Systems Management
Author and maintain job aids, work instructions, and procedural documents.
Manage document control activities within Veeva Quality Vault.
Support administration of SuccessFactors and other quality systems.
Audit & Inspection Support
Support internal audits and regulatory inspections.
Provide accurate documentation and compliance reports.
Assist in audit readiness and quality improvement initiatives.
Required Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Business Administration, or a related field.
Experience
Minimum 2 years of experience in:
Quality Systems (QMS)
Document Management
Regulatory Compliance
Training Administration
Regulated Environments
Required Skills
Quality Management Systems (QMS)
Veeva Vault
SuccessFactors LMS
Document Management
Regulatory Compliance
Power BI
Data Analytics
Audit Support
Training Management
SOP Management
Stakeholder Management
Cross-Functional Collaboration
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Manila |Croatia :
Croatia |Zagreb :
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