Job Description

Responsibilities:

The role is responsible to:

  • Oversee and manage IAC QSC resources in alignment with R&D Quality vision and R&D priorities to deliver high-impact innovation portfolio.
  • Serve as ERDQA lead for onsite R&D business functions including collaborating in a cross-matrixed environment with Clinical Operations, Data Management, Statistics, Global Operations and Transformation, Archiving, CMC Regulatory Affairs, Pharmacovigilance, and IAC site management.
  • Facilitate inspection readiness, represent R&D business and ERDQA for Health Authority inspections and internal audits, including influence and defense.
  • Serve as core team member for the R&D Digital Innovation Governance team. In collaboration with business and IT, develop and implement Artificial Intelligence (AI)-based strategies and solutions to advance continuous process improvement and efficiencies. Represent ERDQA for R&D AI initiatives.
  • Perform Elanco Computer Systems Quality Assurance (CSQA) related activities around the update, integration, and configuration of technology to ensure compliance with relevant standards and regulations.
  • Leverage metrics and expertise to drive performance and improvement.
  • Develop collaborative partnerships with R&D to establish and resource Site and Global Self-Inspection and Quality Plans.
  • Represent R&D Quality on Global Innovation projects as GCP (VICH GL9) and GLP (FDA, EPA, OECD or other) subject matter expert.
  • Conduct GCP (VICH GL9) and GLP assessments, audits, and Quality investigations.

    • Minimum Qualifications:

    Education:

  • Master of science in biology, chemistry, pharmacy, toxicology or similar discipline with a minimum of 10+ years relevant experience.

    • Experience:

  • 5+ years Animal Health development experience, with R&D-related Quality Assurance esp. in Quality Systems, Pharmacovigilance, Regulatory CMC and/or Data Management.
  • Ability to operate in a business focused R&D Quality organization recognized as a collaborator and partner to both the R&D organization and CRO business partners.
  • Knowledge in GCP (VICH GL9), GLP (FDA, EPA, OECD or other) compliance and Good Documentation Practices (ALCOA+), GPV or GMP experience a plus. Knowledge in one or more global regulatory requirements (FDA, EPA, USDA, CFIA, MHRA/VMD, EMA).
  • Knowledge in regulatory requirements [, Good Clinical Practice guidance (GCP, VICH Guideline 9) and / or Good Laboratory Practice (GLP) and 21 CFR Part 11 (ERES)] as related to electronic records, electronic signatures, and Good Documentation Practices (ALCOA+).
  • Applicable knowledge and certifications related to Artificial Intelligence and Machine Learning or willingness to obtain.
  • Familiarity with basic database design, Software Development Lifecycle, software validation, User Acceptance Testing (UAT). Elanco Animal Health Computer Systems Quality Assurance Certified preferred.
  • Expert knowledge of Computer System Quality Assurance requirements.\
  • Preferred qualifications
  • Leads small to medium scale projects with minimum to moderate risks.
  • Knowledge of business processes and the ability to work within the general business hierarchy.
  • Ability to negotiate favorable outcomes while maintaining positive working relationships.
  • Aware of risk-assessment methodologies, and project organization.
  • Able to interpret regulations and policies, and to communicate and respond to associated questions.
  • Ability to define problems, collect and review data, establish facts and draw valid conclusions.
  • Ability to effectively communicate verbally and in writing.
  • Ability to effectively work with teams.
  • Ability to set priorities and manage multiple tasks.

    • Additional Information:

  • Travel: 0%
  • Location: IN, Bangalore - Hybrid Work Environment

    • Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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