Quality Associate - AOR Process (Manufacturing)

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: Quality Associate - AOR Process

The purpose of this position is to provide administrative coordination and technical direction to persons responsible for Annual Outline Review (AOR) and internal approval processes for Outlines of Production (OP) and Special Outlines (SO), which are regulated documents with the USDA Center for Veterinary Biologics. The position interacts with all areas of Manufacturing, Quality and Regulatory Affairs to maintain compliance of operations as stated in the OPs and SOs. You will share successful processes and programs with other sites in Elanco network in order to build cross site processes.

Your Responsibilities:

• Technical Leadership and Training: Provides comprehensive technical guidance, training, and oversight for all aspects of the AOR (Authorized Owner Representative) program, ensuring all personnel are knowledgeable and proficient in its execution.

• Process Management and Facilitation: Leads, facilitates, and enables the AOR process, including the internal OOP (Outline of Production) and SO (Standard Operating procedures) revision and approval workflows. Ensures a smooth and efficient process for all stakeholders.

• Compliance and Alignment: Ensures compliance by aligning related processes and procedures with current regulations, Elanco Global Quality Standards, and Elanco Functional Procedures.

• Continuous Improvement and Collaboration: Collaborates with departmental managers to strategically identify and implement improvements within the AOR process, ensuring efficient operations that deliver quality, timely results, and foster a collaborative environment. Oversees accuracy and compliance of controlled documents against the approved OOP/SO.

• Document Control and Regulatory Collaboration: Ensures timely and accurate updates for OOPs and SOs to support production and laboratory operations. Establishes and maintains a network for collaboration and alignment with regulatory bodies, facilitating effective escalation, investigation, and reporting of outline non-compliance.

What You Need to Succeed (minimum qualifications):

• B.S./B.A. degree or equivalent experience in lieu of degree

• Minimum 5 years of experience in a Quality or Regulatory role.

• Well versed in regulatory requirements, inclusive of GMP/GLP

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

• Good understanding of the relevant USDA regulations.

• Ability to plan, schedule, organize, prioritize, and coordinate project activities in a Team environment.

• Strong verbal, written, organizational, time management, and interpersonal skills with cross-functional groups.

• Must be self-motivated and of high integrity.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status