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.As a member of the globally integrated Elanco R&D Quality Assurance (ERDQA) Leadership Team, the ERDQA Technical Development Quality Lead is accountable for the oversight, direction, and management of the global ERDQA Technical Development Quality team. This role serves as critical business partner to R&D leadership and project teams, with technical quality team accountable to provide quality and scientific technical guidance and oversight to the R&D portfolio, supporting new product development, registrations, licensing, technical transfers, and product launches. In addition, this role provides compliance oversight to ensure that appropriate quality systems, procedures and resources are in place for effective execution of the R&D quality management system. Responsibilities include, but are not limited to:Lead global ERDQA Technical Development Quality team accountable for provision of quality oversight to formulation and analytical technical development activities, from early to late development through registration. Define priorities and strategy to support quality excellence.Build and develop a high performing team, champion talent development in connection with R&Ds strategic goals, quality objectives. Develop resource strategies for efficient operations.Define priorities and strategy to support quality excellence focus on Pharmaceuticals and Biologics oversight. Be a champion for continuous improvement in all aspects of quality management.Strong knowledge of the Elanco Quality system and provides interpretation of the quality management system and applicable regulations to business partners to guide product development activities. Consult and advise on matters related to adherence to regulations for development of products for registration by the FDA, EPA, USDA, EMA, and other regulatory authorities.Demonstrated ability to conduct scientific and compliance review and approval of regulated reports (e.g., manufacture of investigational veterinary product, engineering, and registration batches). Qualified to release investigational study material and other development material as per Elanco Quality requirements. Trains and qualifies team.As Subject Matter Expert, train as well as advise colleagues in providing fit-for-purpose solutions for projects and process challenges around quality issues.Represent R&D Quality for Technical Development Project and Stage-Gate reviews, technical transfers. Along with team, serve as project core team member.Collaborate with cross-functional teams (e.g., Technical Development, Regulatory, TS/MS, Clinical Development, project management) to ensure program goals are met.Lead and guide preparation activities for regulatory authority inspections and/or internal audits to ensure inspection readiness.Participates in the selection of external suppliers and third-party vendors; represents ERDQA on Vendor Oversight Steering Team. Accountable for maintenance of R&D Quality Agreements where required.Supports Elanco s Innovation Strategy through evaluation of Due Diligence opportunities.Develops and executes components of R&D Global Quality and Self Inspection plans as well as develops Quality metrics together with R&D functions.Management of trending change control, deviations, CAPAs and out of specifications.Independently and appropriately escalates issues to Elanco quality and/or R&D management.Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination/harassment and health, safety, and environment policies.Perform any other duties or serve in such other capacity as may be determined by Company management.Basic Qualifications:MS or PhD in Chemistry, Biology, Chemical Engineering, Pharmacy or Pharmaceutical Technology. or demonstrated career experience.5+ years of experience in the pharmaceutical / biologics industry with strong track record of technical expertise and leadership. Animal health experience a plus. Other Preferences:Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.Fundamental understanding of pharmaceutical and biologics discovery, development, and registration.Expert in reviewing and writing technical reports.Strong project management skills, strong communication skills, experience in working with interdisciplinary, multicultural teams.Demonstrated ability to initiate and drive change.Strong understanding and practical application of risk assessment and risk management tools.Fluent in English, , other languages are an additional asset.Auditing experienceOther Information: Travel: up to 20%This role is remote.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
ELANCO
Greenfield Indiana
United States
None
(No Timezone Provided)
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.As a member of the globally integrated Elanco R&D Quality Assurance (ERDQA) Leadership Team, the ERDQA Technical Development Quality Lead is accountable for the oversight, direction, and management of the global ERDQA Technical Development Quality team. This role serves as critical business partner to R&D leadership and project teams, with technical quality team accountable to provide quality and scientific technical guidance and oversight to the R&D portfolio, supporting new product development, registrations, licensing, technical transfers, and product launches. In addition, this role provides compliance oversight to ensure that appropriate quality systems, procedures and resources are in place for effective execution of the R&D quality management system. Responsibilities include, but are not limited to:Lead global ERDQA Technical Development Quality team accountable for provision of quality oversight to formulation and analytical technical development activities, from early to late development through registration. Define priorities and strategy to support quality excellence.Build and develop a high performing team, champion talent development in connection with R&Ds strategic goals, quality objectives. Develop resource strategies for efficient operations.Define priorities and strategy to support quality excellence focus on Pharmaceuticals and Biologics oversight. Be a champion for continuous improvement in all aspects of quality management.Strong knowledge of the Elanco Quality system and provides interpretation of the quality management system and applicable regulations to business partners to guide product development activities. Consult and advise on matters related to adherence to regulations for development of products for registration by the FDA, EPA, USDA, EMA, and other regulatory authorities.Demonstrated ability to conduct scientific and compliance review and approval of regulated reports (e.g., manufacture of investigational veterinary product, engineering, and registration batches). Qualified to release investigational study material and other development material as per Elanco Quality requirements. Trains and qualifies team.As Subject Matter Expert, train as well as advise colleagues in providing fit-for-purpose solutions for projects and process challenges around quality issues.Represent R&D Quality for Technical Development Project and Stage-Gate reviews, technical transfers. Along with team, serve as project core team member.Collaborate with cross-functional teams (e.g., Technical Development, Regulatory, TS/MS, Clinical Development, project management) to ensure program goals are met.Lead and guide preparation activities for regulatory authority inspections and/or internal audits to ensure inspection readiness.Participates in the selection of external suppliers and third-party vendors; represents ERDQA on Vendor Oversight Steering Team. Accountable for maintenance of R&D Quality Agreements where required.Supports Elanco s Innovation Strategy through evaluation of Due Diligence opportunities.Develops and executes components of R&D Global Quality and Self Inspection plans as well as develops Quality metrics together with R&D functions.Management of trending change control, deviations, CAPAs and out of specifications.Independently and appropriately escalates issues to Elanco quality and/or R&D management.Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination/harassment and health, safety, and environment policies.Perform any other duties or serve in such other capacity as may be determined by Company management.Basic Qualifications:MS or PhD in Chemistry, Biology, Chemical Engineering, Pharmacy or Pharmaceutical Technology. or demonstrated career experience.5+ years of experience in the pharmaceutical / biologics industry with strong track record of technical expertise and leadership. Animal health experience a plus. Other Preferences:Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.Fundamental understanding of pharmaceutical and biologics discovery, development, and registration.Expert in reviewing and writing technical reports.Strong project management skills, strong communication skills, experience in working with interdisciplinary, multicultural teams.Demonstrated ability to initiate and drive change.Strong understanding and practical application of risk assessment and risk management tools.Fluent in English, , other languages are an additional asset.Auditing experienceOther Information: Travel: up to 20%This role is remote.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