• Job Description

  Req#: R0015370

  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.

  Position Description:

  This position is accountable for Quality oversight and lifecycle management of assigned animal nutritional products, contract manufacturing organizations (CMO’s) and suppliers ensuring that Elanco products meet all legal and internal requirements. This role will actively collaborate with quality, regulatory, technical services, operations, and supply chain counterparts to support quality document reviews/approvals and batch release.

  Functions, Duties, Task:

  • Provide Quality Oversight & release activities for Elanco Externally Manufactured products with emphasis but not limited to nutritional products such as animal feed additives and supplements.

  • Leverage subject matter expertise in the review and approval of technical documents supporting the commercial products, including manufacturing technical documents in line with Food Safety Plans, HACCP/HARPC in support of Animal Food Industry requirements

  • Ensure development of continuous improvement strategies where applicable based on Animal Nutritional regulatory requirements including US and EU Animal Feed/Food legislation (FSMA, EU Regs and Directives)
  • Partner with technical services & manufacturing operations to assure that CMO deviations are compliant, root cause and CAPA plans are appropriate and implemented in a timely manner.
  • Partner with supply chain counterparts to support timely product release to the market.
  • Assure the robust selection and on-boarding of CMO’s / Suppliers in compliance with the regulatory, cGMP requirements and the Elanco Quality Manual / Directives that apply to the product categories.
  • Manage and support CMOs / Suppliers relationships. Facilitates open communication and cooperation with high integrity.
  • Manage and support the resolution of issues at CMOs/Suppliers, escalates issues appropriately and timely and drive corresponding continuous improvement initiatives.
  • Support and guide internal functions within Elanco and external partners (e.g training, issue resolution, interpretation of standards, inspection readiness, etc.)
  • Drive the utilization of Risk Management principles for CMOs/Suppliers oversight and monitor CMOs / Suppliers QA performance metrics and reports.
  • Ensure Quality Plans are established and executed appropriately
  • Provide support for new launches/acquisitions to ensure compliant systems and procedures are in place to manage new products
  • Develop and execute approved quality procedures (SOP’s) applicable to the EEM organization and quality function: product documentation review, product release, deviation review/approval, CAPA effectiveness monitoring, change management, laboratory investigation review/approval, complaint investigation review/approval
  • Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training
  • Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

  Basic Minimum Qualifications:

  • Degree in chemistry, pharmacy, engineering, Food Science or other technical areas of study in relevant field of study and equivalent years of experience in a Feed/nutrition industry.

  Experience:

  • Demonstrated experience & expertise in the Animal Nutrition field, with practical experience in the application quality systems to the manufacture of nutritional products. Additional experience in pharmaceutical manufacturing preferred.
  • Strong understanding of the range of Animal Nutritional regulatory requirements including US and EU Animal Feed/Food legislation (FSMA, EU Regs and Directives). Globally relevant regulatory knowledge preferred.
  • Demonstrated experience with Food Safety Plans, HACCP/HARPC in support of Animal Food Industry requirements.
  • Effective influencing & collaboration abilities – working across various cultures, languages, work styles and levels within a global organization.
  • Demonstrated problem solving, complex investigations, quality risk management, project management and decision-making skills.

  Language requirements:

  • Fluent (written & verbal) in English
  • Additional language skills would be highly valued

  Additional Preferences:

  • PCQI trained

  Other Information:

  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • Expected Travel: Up to 20%

  Elanco currently anticipates that the base salary for this position could range from $94,000.00 to $124,000, depending partly on the successful candidate’s qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees.

  #LI-JH1

  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

• About the company

  Elanco is a world leader in developing innovative products and solutions that enhance animal health, empowering the people that raise and care for animals

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