Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com. (Elanco only)
Position Description: This position is accountable for Quality oversight and lifecycle management of assigned Elanco finished drug products; API; contract manufacturing organizations (CMO’s) and suppliers ensuring that Elanco products meet all legal and internal requirements
Functions, Duties, Task:
Provide Quality Oversight & release activities for Elanco Externally Manufactured Medicinal and Non Medicinal products. This may include but not limited to the following: parenteral, solid oral dose, non-sterile liquid, premix, API, implant, 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, 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 for assigned API CMOs/Suppliers.
Provide support for new API 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 are compliant, root cause 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.
Bachelor’s Degree in chemistry, pharmacy, engineering.
At least 5 years' of pharmaceutical or animal health manufacturing experience
At least 3 years' of experience within the quality manufacturing organization
Must be familiar or solid oral dosage forms and premix.or nutritionals
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.
Demonstrated technical leadership experience in the pharmaceutical industry, specifically supporting the production of finished drug product; API; pre-mixes and/or enzymes
Demonstrated cGxP experience, specifically leading complex investigations; deviation / CAPA management; change leadership and risk management
Contemporary working knowledge, including inspections, of the Amercia’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 (OE / Lean) leadership – can comfortably quantify & articulate the impact of OE projects and their impact (monetary, headcount, efficiency) to an organization
Masters in relevant sciences and/or engineering
Expected Travel : Up to 20%
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.