USDA Quality Advisor, Biotech Network

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: Quality Advisor, Biotech Network

As a Biotech Network Quality Advisor, you will play a pivotal role in ensuring robust support for Quality processes related to our multi-site USDA licensure including regulatory submissions and deviation management.

This role involves extensive cross-functional collaboration to drive continuous improvement in quality performance and culture across multiple sites. 

Your Responsibilities: 


* Help define strategic action plans and priorities for the Quality agenda to drive continuous improvement. Provide tactical support for Quality Assurance and compliance processes and initiatives. 


* Act as an Alternate Liaison for Elanco’s USDA Establishment, managing submissions and interactions with USDA-CVB. 


* Leverage external benchmarking and networking to pinpoint strategic improvements for Compliance and overall performance.

Construct robust business cases, articulate strong rationales and value propositions, and champion these projects/initiatives for Senior Leader approval. 


* Serve as a key team player in Deviation Review Boards, guiding investigations and driving excellence in deviation handling. 


* Coach and mentor colleagues in technical writing for regulatory submissions, conduct on-site visits to assess Quality System effectiveness and lead sites through optimization initiatives. 

 

What You Need to Succeed (minimum qualifications): 


* Bachelor's degree in biochemistry, chemistry, virology, biology, or a science-related field.  


* A minimum of 10 years of experience in the vaccine/Biotech industry. 


* Thorough knowledge of regulatory requirements for Biotech products (USDA 9CFR, FDA, EU-GMP) and deep technical knowledge of manufacturing processes and analytical methods for Biotech products, including Sterility Assurance. 

What Will Give You a Competitive Edge (preferred qualifications): 


* Master’s or PhD in biochemistry, chemistry, virology, biology, or a science-related field. 


* Demonstrated coaching and mentoring capabilities. 


* Ability to set up partnerships with rele...