This position will be 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. 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 Medicinal and Non-Medicinal products. This may include but not limited to the following: parenteral, solid oral dose, non-sterile liquid, 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, 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.
- University Degree (minimum of a Bachelor’s degree) in relevant field of study and 8 years of experience in a GMP environment or 15 years of relevant experience in lieu of a degree.
- Demonstrated technical leadership experience in the pharmaceutical industry, specifically supporting the production of finished drug product; API; pre-mixes, Solid Oral Dose, Injectables
- Demonstrated cGxP experience, specifically leading complex investigations; deviation / CAPA management; change leadership and risk management
- Contemporary working knowledge, including 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 (OE / Lean) leadership – can comfortably quantify & articulate the impact of OE projects and their impact (monetary, headcount, efficiency) to an organization
- Fluent (written & verbal) in English
- Additional language skills would be highly valued – but not essential
- Additional Degree in chemistry, pharmacy, engineering or other technical areas of study
- 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