Senior Associate – Clinical Operations (R&D Quality Systems & Global 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 to ensure compliance, inspection readiness, and operational excellence across global R&D functions.
The role focuses on quality systems administration, training compliance, document management, audit support, regulatory compliance, Power BI reporting, and stakeholder engagement while leveraging digital technologies and AI-enabled solutions to enhance operational efficiency and compliance visibility.
Key Responsibilities
Quality Management System (QMS) Operations
Independently manage R&D Quality Management System activities.
Monitor compliance metrics, document tracking, and status reporting.
Support implementation and maintenance of quality processes.
Ensure quality records remain accurate, complete, and audit-ready.
Global Training Administration
Execute and support the Global Quality Training System.
Ensure:
Right Training
Right Employee
Right Timing
Monitor training completion and compliance status.
Maintain training records within Learning Management Systems (LMS).
Support onboarding and continuous learning initiatives.
Document Management & Control
Maintain document control processes within:
Veeva Quality Vault
SuccessFactors
Other R&D Quality Systems
Develop and maintain:
Job Aids
Work Instructions
Operational Documents
Training Materials
Ensure documentation follows quality and regulatory requirements.
Data Analytics & Compliance Reporting
Utilize Power BI to:
Create Compliance Dashboards
Track Training Metrics
Monitor Quality Performance
Identify Compliance Trends
Generate reports for R&D leadership.
Support compliance gap analysis and performance monitoring.
AI & Digital Enablement
Apply AI-enabled solutions to improve productivity and reporting efficiency.
Support adoption of digital tools for compliance monitoring.
Utilize technology to streamline quality and training operations.
Audit & Inspection Support
Support internal audits and regulatory inspections.
Provide organized documentation and compliance evidence.
Assist with audit preparation and inspection readiness activities.
Support responses to audit observations and compliance actions.
System Administration
Serve as a key user and administrator for:
Veeva Quality Vault
SuccessFactors
Power BI
Adobe Acrobat
Microsoft Office Applications
Maintain system data integrity and compliance.
Provide user support and guidance.
Cross-Functional Collaboration
Collaborate with:
Clinical Operations
R&D Teams
Regulatory Affairs
Quality Assurance
Global Stakeholders
Align deliverables across functions.
Facilitate effective communication and issue resolution.
Continuous Improvement & Operational Excellence
Identify process improvement opportunities.
Support implementation of operational excellence initiatives.
Contribute to quality system enhancements.
Drive efficient and compliant execution of assigned responsibilities.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Business Administration
Related Scientific Discipline
Experience
2+ years of experience in:
Clinical Operations
Quality Systems
Document Management
Regulatory Compliance
Training Administration
Regulated Environments
Preferred Experience
Experience supporting:
Clinical Research
R&D Operations
Pharmaceutical or Biotechnology Industries
Quality Management Systems (QMS)
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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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Mexico |northeastern :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | Renfrew | North York | Australia | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Be'Er Sheva | Kfar Saba | Netanya | Yavne | Tel Aviv |Remote :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
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Prague |Chile :
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Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |