Overview

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.

Elanco is a Global Leader in pet and farm animal health products. With almost $5 Billion in revenue, our 9000 employees manufacture and market over 200 brands in 90 countries. Elanco Establishment 196 sites (Fort Dodge, IA, Winslow, ME, Elwood, KS) manufacture multi-species vaccines and immunological products for the Global market which accept USDA registrations. We produce inactivated and modified live vaccine products, as well as innovative immunological products (monoclonal antibodies). Our processes include fermentation, egg-based and cell-based production of antigens and monoclonal antibodies, inactivation, downstream processing, formulation, liquid filling, and lyophilization of finished products.

Reporting to the Biotech Global Quality Leader, the Est 196 Network Advisor plays a pivotal role to ensure adequate support is provided to the Quality processes involving Est 196, including but not limited to: Form 2008 review and submission process, Deviation and CAPA Review Boards, ESR and other documents’ write-up and review (technical assessments, position papers). The incumbent will be collaborating cross-functionally with multiple teams on the 3 sites to achieve desired outcomes and drive continuous improvement in performance and quality culture.

Functions, Duties, Tasks:

  • At the strategic level: help define action plans and priorities for the mid and long-term horizons (3-5 years) for Est 196 Quality agenda to drive continuous improvement in quality performance. Collaborate and partner with local and global entities (Sites, Sterility Assurance group, Global Technical Services, Global Labs, Central Quality) to identify strategic workstreams. Participate in the governance bodies and help ensure On Time In Full execution of the milestones.
  • Responsibilities as an Alternate Liaison for Elanco’s USDA Establishment including representing Elanco in interactions with USDA, handling of submissions and correspondences with the USDA-CVB, with a focus on compliance and associated technical discussions.
  • Through external benchmarking and networking, identify opportunities for improvements to Compliance and overall performance across Est 196. Build business cases, present rationales and value propositions, and drive projects/initiatives to approval by Senior Leaders.
  • Provide tactical support for Quality Assurance and compliance processes and initiatives.
  • Be a key team player in Deviation Review Board, providing insight and informed opinion, guiding the investigation teams throughout the process. Drive excellence in approach to deviation/event handling, driving the teams towards efficiency and effectiveness in terms of root cause outcomes, CAPAs and impact assessments.
  • Coach and mentor colleagues in technical writing, for submissions to regulators.
  • Through on-site visits verify the effectiveness of Quality Systems– and guide sites through optimization programs of same.
  • Support identification and recruitment of resources for Quality within Est 196.
  • Prepare documentation (pre-reads, dashboards, reports…) to ensure efficient execution of Est 196 governances.
  • Travel to the Est 196 sites and provide direct support to the teams.

Minimum Qualifications:

  • Master’s degree in biochemistry, chemistry, virology, biology, or science related field required; PhD preferred.
  • Minimum 10 years of experience in vaccine/Biotech industry.
  • Thorough knowledge of regulatory requirements for Biotech products (Human or Animal products – UDSA 9CFR, FDA, EU-GMP).
  • Deep technical knowledge of manufacturing processes and analytical methods for Biotech products, including Sterility Assurance
  • Demonstrated coaching/mentoring capabilities, to be able to support teams and individuals’ development.
  • Ability to set up partnership with relevant Functions to resolve quality & compliance issues.
  • Versatility in conflict resolution, problem solving and working with cross functional teams.

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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

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Tagged as: MID TO SENIOR LEVEL

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