Quality Assurance Senior Associate at Elanco in greenfield, Indiana

Job Description:

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 Elanco materials and finished drug 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 maintain CMO inspection readiness and support quality document reviews/approvals and batch release

Functions, Duties, Task:

• Provide Quality Oversight activities for Elanco Externally Manufactured products. Support includes, but not limited to, the following technologies:  parenteral, oral solid dose, non-sterile liquid & Nutritional Health, premix, API, and EPA/parasiticide products.


• Assure the robust selection and on-boarding of CMO’s / Suppliers in compliance with the regulatory, cGMP requirements and the Elanco Quality Manual / Directives


• Manage and support positive CMOs / Suppliers relationships.  Facilitates open communication and cooperation with high integrity.


• Manage and support the resolution of issues at CMOs/Suppliers, escalate 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 for assigned CMOs/Suppliers.


• Provide support for new product launches/acquisitions to ensure compliant systems and procedures are in place to manage new products


• Partner with technical services & manufacturing operations to assure that CMO deviations, complaints, root causes, and CAPA plans are appropriate and implemented in a timely manner.


• 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


• Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including process validation reports, manufacturing technical documents, stability reports and process flow diagrams. Ensure development of continuous improvement strategies if applicable.


• 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 Qualification:

• University Degree in relevant field of study (chemistry, pharmacy, engineering or other technical areas of study)


• Minimum 15 years demonstrated Quality/technical leadership experience in the pharmaceutical industry, specifically supporting the production of API’s


• Demonstrated cGxP experience, specifically leading complex investigations; deviation / CAPA management; change leadership and risk management


• Current working knowledge, including audit/inspections, of the America’s regulatory environment – FDA; MAPA etc.


• Effective influencing & collaboration abilities – working across various cultures, languages, work styles and levels within a global organization


• Demonstrated problem solving, quality risk management, project management and decision-making skills


• Continuous Improvement (Operational Excellence / Lean) leadership – can comfortably quantify & articulate the impact of simplification projects and their impact (monetary, headcount, efficiency) to an organization


• Additional language skills would be highly valued – but not essential

Other Information:

• Expected Travel: Up to 20%

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

Salary: