Group Lead - Quality System & Compliance

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role:

Position Description:

This position supports the Research & Development organization by providing site-based leadership for Elanco R&D Quality Assurance (ERDQA) Quality Systems & Compliance (QSC) and ensuring quality and compliance oversight of R&D related functions located at the IAC. 

Your 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...