Lilly Consultant-Quality Vaccines-EEM ROW in Greenfield, Indiana
To drive and maintain improvements in the quality framework and processes of the vaccine quality network, to ensure the products and processes are effective and compliant with the applicable regulatory and company requirements.
This role provides network level oversight and guidance to assist network sites with the implementation and standardization of Elanco Quality Systems. The QA Consultant works as a team member within the Quality organization to identify opportunities for continuous improvement, benchmark for solutions inside and outside of the network, and facilitate implementation of new standards and practices.
Functions, Duties, Task:
Drive the implementation and harmonization of Global Quality standards in alignment with applicable regulations to assure an effective quality manufacturing oversight system within the Vaccine/ROW EEM networks
Preparation of KPI reports for ELT and M&Q leadership forums to assure appropriate Q governance and tracking of identified corrective actions in alignment with defined review schedules.
Assure effective KPI’s and metric reporting to allow assessment of supplier/CMO performance.
Work directly with the Quality systems and strategy team to develop standards and policies for the Manufacturing Quality Units within Elanco to assure compliance with applicable regulatory requirements, Elanco Q Standards, and Industry Standards
Maintenance and revision of Elanco Functional Procedures in alignment with periodic review schedules and Elanco Standard Revision Gap assessments.
Develop and lead working groups to influence the content of the Elanco standards and EFP’s, acting as a key resource to resolve issues and differing opinions
Represent the Vaccine and ROW EEM network teams where cross collaboration with other functions/and co-ordination of resources are required.
Develop training programs for EFP Quality Systems deployment
Support the Operational Excellence Journey within the Vaccine/ROW EEM network through representation and advocacy of OE principles.
Provide additional support to sites for inspection management and audit preparation as required.
Facilitate the Vaccine Quality Lead Team, consisting of the Director of Vaccine Quality and the Site Quality Leaders
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, 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
Demonstrated experience in the pharmaceutical industry
Experience in Quality Operations, Manufacturing and/or other relevant operational areas.
Strong understanding of varied regulatory requirements related to vaccine manufacturing
Demonstrated learning agility
Strong understanding of risk assessment and risk management fundamentals/tools
Fluent in speaking / writing English
Desired, Masters or PhD in Life Sciences or Management
Previous experience in vaccine manufacturing
Knowledge of Continuous Improvement Six Sigma and Lean Principles
Expected Travel : Less than 20-30%
Lilly 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. #LI-POST
Quality Vaccines Leader
Bachelor’s Degree in Science (Biochemistry; Chemistry; Engineering Microbiology)
5-7 years experience in a manufacturing environment
2 years of Continuous Improvement Six Sigma and Lean Principles
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
Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana
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