Clinical Quality Assurance Manager

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: 

This role supports the Research & Development (R&D) Clinical Development organization by providing quality oversight and consultative support for animal health research and development activities as part of Elanco R&D Quality Assurance (ERDQA).

Partners with the business to meet the requirements of both Elanco and applicable regulatory authorities in support of global animal registrations.

Your Responsibilities:


* Responsible for planning and conducting Quality oversight/audit activities for veterinary Good Clinical Practice studies.


* Completes and issues audit reports, observation reports, and reviews and approves responses and corrective actions for study audits.


* Plans and executes process audits (self-inspections) of R&D internal processes.


* Provides quality oversight and compliance consultation to the R&D organization.


* Coordinates preparation activities for regulatory authority inspection of clinical investigator sites, as well as supporting these inspections.

What You Need to Succeed (minimum qualifications):


* Master in Life Sciences or Bachelor of Science Degree in biology, animal science, pharmacy or a related field.


* A minimum of 7 years of experience in providing quality oversight or monitoring veterinary clinical and safety studies completed in support of pharmaceuticals submissions.


* Knowledge of Quality Systems and VICH Guideline 9


* Fluency (reading and writing) in Portuguese and English.

What will give you a competitive edge (preferred qualifications):


* Proven record in delivering training to a diverse audience on compliance topics.


* Proven abilities in business partnering and influencing of scientific leaders.

Additional Information: 


* Travel: Up to 15%


* Location: São Paulo Office


* Hybrid Work model: 3 times a week in the office

Elanco Benefits and Perks:

We offer a comprehensive benefits package focused on financial, physical, and mental well-being, while encouraging our employees to pursue our purpose! Some highlights include:


* Monthly salary starting from R$ 15,700


* Corporate ...