India's DMPLOI - Jobs & Networking App
Elanco Animal Health
Elanco Animal Health is a global leader in animal health, dedicated to innovation and delivering products and services that prevent and treat diseases in farm animals and pets. With a strong commitment to improving animal well-being, Elanco operates with a vision of Food and Companionship Enriching Life.
The company promotes a diverse and inclusive work environment, encouraging innovation, collaboration, and career growth.
Job Details
- Position: Manager – R&D Quality & Compliance
- Location: Bangalore
- Job Type: Full-Time
- Job ID: R0023317
Job Overview
This role supports Elanco’s Research & Development (R&D) organization by providing leadership in Quality Assurance (QA), Quality Systems & Compliance (QSC), and ensuring regulatory compliance across R&D functions.
You will work closely with cross-functional teams including Clinical Operations, Data Management, Regulatory Affairs, and Pharmacovigilance to maintain high-quality standards and inspection readiness.
Key Responsibilities
- Lead and manage R&D Quality Systems & Compliance (QSC) activities
- Ensure inspection readiness for regulatory audits and health authority inspections
- Collaborate with cross-functional teams across R&D and IT
- Drive AI-based innovation strategies for process improvement
- Oversee Computer Systems Quality Assurance (CSQA) compliance
- Conduct audits, assessments, and quality investigations
- Develop and implement quality plans and self-inspection programs
- Act as subject matter expert for GCP (VICH GL9) and GLP standards
Qualification
- Master’s degree in:
- Biology
- Chemistry
- Pharmacy
- Toxicology or related discipline
Experience Required
- Minimum 10+ years of relevant experience
- At least 5+ years in Animal Health R&D Quality Assurance
- Strong experience in:
- Quality Systems
- Pharmacovigilance
- Regulatory CMC
- Data Management
Required Skills
- Strong knowledge of:
- GCP (VICH GL9) & GLP regulations
- Good Documentation Practices (ALCOA+)
- 21 CFR Part 11 (Electronic Records & Signatures)
- Understanding of global regulatory agencies (FDA, EMA, MHRA, etc.)
- Experience with AI/ML applications (preferred or willingness to learn)
- Knowledge of:
- Software Development Lifecycle (SDLC)
- Computer System Validation (CSV)
- User Acceptance Testing (UAT)
Preferred Skills
- Project management and leadership abilities
- Risk assessment and problem-solving skills
- Strong communication and collaboration skills
- Ability to manage multiple priorities effectively
Why Join Elanco?
- Work with a global leader in animal health
- Be part of innovative R&D and digital transformation initiatives
- Inclusive and collaborative work culture
- Opportunities for career growth and learning
📢 How to Apply
Interested candidates can apply directly through the official Elanco careers portal.
To apply for this job please visit elanco.wd5.myworkdayjobs.com.
