Responsible Person - Quality and Product Release

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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: Responsible Person (RP), Quality

The purpose of this position is to provide final approval for filled product serials at the Elanco Fort Dodge vaccine site and submit to USDA for release to US market.

This position will provide oversight of Quality Assurance processes ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production and Elanco standards, as well as technical guidance, training, and oversight regarding Quality and GMP for the site.

Responsible Person is responsible for identifying and implementing new quality initiatives, systems, and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage.

Your Responsibilities:


* Provide oversight of Quality Assurance processes ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production and Elanco standards.


* Ensure product quality and compliance with regulatory requirements for released batches through review and assessment of batch documentation, analytical data, and associated deviations, change controls and CAPA.


* Implement SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.


* Assist with internal, regulatory, or corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.


* Provide training and guidance to personnel relating to GMP principles, quality procedures, and regulatory requirements.

What You Need to Succeed (minimum qualifications):


* Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or Engineering.


* 10 years in a regulated pharmaceutical /vaccine manufacturing environment.


* ​Thorough understanding of the principles and methods of vaccine manufacturing and formulation, sterility assurance, Quality Control testing and analysis, packaging, storage, and distribution.


* Must demons...