Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
This role provides quality oversight and consultative support for animal health research and development activities at Fort Dodge. Partners with the business to meet the requirements of both Elanco and applicable regulatory authorities in support of global animal registrations. This role proactively drives compliance through implementation and monitoring of Elanco Quality Standards, training and compliance tools. Partners with other Elanco Quality Organizations to assure GxP compliance is achieved.
Responsible for planning and conducting oversight/audit activities for veterinary Good Clinical Practices (vGCP), Good Laboratory Practice (GLP) and Good Research Practices (GRP) studies. Activities include independent planning and execution of protocol audits, in-life or live phase audits, data audits, and final and statistical report audits, and oversight of work completed at third parties. Issues QA Statement where applicable.
Provides Site Quality Leadership to R&D functions. Assure compliance with cGMP, GCP, GLP and GRP regulations for all R&D activities at Fort Dodge
Develops and executes components of site and global Q plans/quality system and develops Q metrics together with R&D functions to drive continuous improvement.
Independently evaluates scientific, and quality aspects of global/local projects and procedures to assure compliance with relevant requirements.
Recognized as expert in quality compliance for GRP, GCP, GLP and cGMP and partners with R&D scientists to assure that relevant R&D activities conducted comply with said regulations.
Develops strong partnerships and positively influences the R&D quality culture at Fort Dodge through providing guidance and support on overall quality strategy and to meet requirements of both Elanco and applicable regulatory authorities
Assures adequately trained and knowledgeable quality resources are available to support R&D for projects assigned.
Responsible for providing Sponsor oversight/audit activities for GLP studies completed at third parties: study protocol reviews, in-life site visits, and data/reports reviews.
Issues inspection reports, and reviews and approves responses and corrective actions for study audits. Independently follows up on audit responses and judges appropriateness of responses.
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.).
Provide quality and compliance training to R&D and quality partners. Independently develops training presentations on GxP or compliance topics as needed
Builds and maintains relationships with business partners internal and external to R&D Quality and/or key R&D business area. Interacts with regulators, customers, and other outside stakeholders on business issues.
Independently and appropriately escalates issues to Elanco quality and R&D management.
Responsible for providing quality oversight and compliance consultation to the R&D organization.
Coordinate preparation activities for regulatory authority inspections to enable inspection readiness at the site. Takes delegation for hosting inspections for research work (e.g. FDA, EPA, etc.)
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, anti-harassment, and health, safety and environment (HSE) policies.
Perform any other duties or serve in such other capacity as may be determined by Company management.
Bachelor’s Degree in Life Sciences or Animal Science
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Demonstates extensive knowledge in providing quality oversight or monitoring studies completed in support of pharmaceuticals submissions regulated by the FDA, EPA and/or EMEA (5+ years’ experience.)
Demonstrated working experience to GLP and/or GCP.
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.
Desired, Masters or PhD in Life Sciences
Experience providing Sponsor QA oversight of Good Laboratory Practice studies completed at third parties.
Registered Quality Assurance Professional in GLP or GCP.
Relocation package may be provided
Competitive benefit package
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