Position Description:

- Provides quality oversight support for animal health R&D activities at the site and in support of global projects, partnering with the business to meet the requirements of both Elanco and applicable regulatory authorities. Focus on QA oversight for local R&D activities in the area of PV, Regulatory CMC and Global Operations.

- Develops strong partnerships and collaborations with Elanco R&D teams members for Quality related consultation.

- Proactively drives compliance through implementation and monitoring of Elanco Quality Standards, training and compliance tools. Partners with other Elanco/Lilly Quality Organizations to assure GXP compliance is achieved.

Functions, Duties, Task:

1. Responsible for providing Quality oversight to all functions within the R&D organization at the site and for global projects.

2. Responsible for establishing and maintaining the quality systems for the site. Supports or drives the rollout of quality processes for the site or function.

3. Coordinate preparation activities for regulatory authority inspections to enable inspection readiness at the site.

4. Provide quality and compliance training to R&D personnel. Independently develops training presentations on GXP or compliance topics as needed.

5. Responsible for maintenance (initiation, review, renewal, etc.) of Quality Agreements with third parties for development activities.

6. Establishes key relationships with contacts outside of R&D Quality or key business area. Identifies internal and external customer requirements and develops solutions.

7. Responsible for planning and conducting GXP oversight activities: GPV, GRP, GCP or GLP study protocol, in-life and data/reports reviews/audits; site process self-inspections; and GRP, GMP, GLP or GCP qualification and oversight activities for work completed at third parties.

8. Responsible for the execution of the site quality assurance and compliance strategy for R&D through appropriate use of GPV, GCP (VICH GL9), OECD GLP, GMP, USDA and/or other relevant external standards and Elanco/Eli Lilly Quality System requirements.

9. Provide Quality support to Regulatory affairs & R&D Global Operations for site specific issues.

10. Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

11. Perform any other duties or serve in such other capacity as may be determined by Company management.

Education:

- Bachelor's Degree (minimum) in Pharmacy, Science, Engineering, or related field, or equivalent relevant experience.

Experience:

- Demonstrated vaccine/animal health development experience, with a proven track record in R&D-related Quality Assurance esp. in Quality Systems, Pharmacovigilance, Regulatory CMC and/or Data Management.

- Experience with quality systems processes and training.

- Proven ability to operate in a business focused R&D Quality organization recognized as a collaborator and partner to both the R&D organization and CRO business partners.

- Strong knowledge in one of the following: GPV, GCP (VICH GL9), GMP or GLP compliance in one or more global regulatory requirements (USDA, CFIA, MHRA/VMD, EMA).

- Strong technical knowledge in one or more of the following fields for development: technical development, biologics manufacturing, microbiology, clinical and/or safety.

- Experience with quality compliance for regulatory submissions in support of veterinary health registrations.

- Leads medium scale projects or programs with moderate risks.

- Has comprehensive business and technical knowledge to provide opinion and ensure legal, regulatory and quality compliance.

- Knowledge of PC tools including all MS Office applications and Internet

- Knowledge of business process and the ability to work within the general business hierarchy.

- Ability to negotiate favorable outcomes while maintaining positive working relationship.

- Skilled in risk-assessment methodologies, and project organization.

- Able to interpret regulations and policies, and to communicate and respond to associated questions.

- Ability to define problems, collect and review data, establish facts and draw valid conclusions.

- Ability to effectively communicate verbally and in writing.

- Demonstrated leadership skills. Ability to effectively work with teams.

- Strong analytical skills. Ability to set priorities and manage multiple tasks.

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