Quality Assurance Advisor (Teleworker)
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Quality Assurance Advisor will provide quality oversight for animal health research and development activities in support of global projects. The incumbent will partner with the business to meet the requirements of both Elanco and applicable regulatory authorities in support of global animal product registration. This role will proactively drive compliance through implementation and monitoring of Elanco Quality Standards, training, and compliance tools. It will also partner with other Elanco Quality Organizations to assure GxP compliance is achieved.
- Has comprehensive business and technical knowledge to provide opinion and ensure regulatory and quality compliance.
- Responsible for providing Quality oversight to all functions within R&D for global projects.
- Responsible for planning and conducting oversight/audit activities for veterinary Good Clinical Practices (GCP according to VICH GL9) and/or pivotal Good Research Practices (according to internal GCP requirements) studies. Activities include independent planning and execution of protocol reviews and/or oversight of work completed at third parties. Issues QA statement for clinical study audits.
- Responsible for providing Sponsor oversight/audit activities for Good Laboratory Practice (GLP) studies completed at third parties: study protocol reviews, in-life phase audits and data/reports reviews. Advise and collaborate with Elanco responsible personnel to help assure GLP compliance.
- Completes and issues inspection reports, observation reports, and reviews and approves responses and corrective actions for study audits. Independently follows up on audit responses and assesses the appropriateness of responses. Proficient in more than one GxP standard area.
- Plan and execute process audits (self-inspections) of R&D internal processes (e.g., archive, data management processes, monitoring process, quality system driven activities, etc.). Interacts with regulatory, customers, and other outside stakeholders on business issues.
- Leads medium scale projects or programs with moderate risks.
- Performs quality oversight of regulatory submission documentation for technical and/or clinical operations.
- Builds and maintains relationships with business partners internal and external to R&D Quality and/or key Innovation/R&D business areas.
- Independently and appropriately escalates issues to Elanco quality and/or R&D management.
- Responsible for providing quality oversight and compliance consultation to the R&D organization.
- Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination/harassment and health, safety, and environment (HSE) policies.
- Provide quality and compliance training to R&D and quality partners. Independently develops training presentations on GXP or compliance topics as needed.
- Perform any other duties or serve in such other capacity as may be determined by Company management.
- Bachelor’s Degree (minimum) in Science, Animal Science, or a related field; or equivalent experience in lieu of a degree.
- 5 years of quality oversight experience in support of biologicals and/or pharmaceuticals submissions including those regulated by the USDA-CVM, FDA-CVM and/or EMA
- Demonstrated working experience to veterinary Good Clinical Practices (GCP) requirements (VICH GL9) for animal health products.
- Proven track record in delivering training; to a diverse audience on compliance topics.
- Proven abilities in business partnering and influencing of senior scientific leaders.
- Strong understanding of risk assessment and risk management fundamentals/tools.
- Working knowledge of quality systems and processes.
- Expected travel: up to 30%
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
By applying you agree to our Terms of Service