At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Position Description:
As the central quality contact for Elanco GmbH, Cuxhaven and Elanco Animal Health GmbH (EAH), Monheim organization, the Quality Manager advises, decides, reports, consults and escalates quality matters related to acting as a Marketing Authorization holder to the appropriate management and functional leaders when needed. The Quality Manager provides independent quality oversight of GxP service providers in scope of the activities mentioned above and supports other responsible person(s) to ensure products meet the quality that customers and the regulators expect.
Functions, Duties, Tasks:
- Ensure that all operations of Elanco GmbH and EAH GmbH related to acting as a Marketing Authorization holder comply with applicable GxP, other applicable company quality standards, local regulations and appropriate quality agreements are in place.
- In partnership with local affiliate Quality and Supply Chain provide Quality Oversight of Elanco co-promotors
- Support other nominated responsible person(s) to fulfill their legal obligations, e.g. the Qualified Person for Pharmacovigilance (QP PV)
- Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective & preventative actions (CAPA), use of a Quality Plan and review of metrics
- As a MA holder, ensure a system is maintained products are manufactured in compliance with (EU) 2019/6 and TAMG as applicable, comply to their specification and are distributed in compliance with the specified conditions.
- Act as Quality contact for respective surveillance agencies
- Accountable for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, procedure review & approval, maintenance of the Quality Plan, and recall management.
- Organize, prepare and hold PQR Review board meetings
- Manage agency inspections related to MAH’s activities of Elanco GmbH and Elanco Animal Health GmbH (EAH)
- Manage requests from authorities related to Authorities’ analytical testing of products in the market “Staatliche Chargenprüfung” (organize sampling, reference standard material, documentation)
- Raise Notifications to Management, if and when required
- Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Minimum Qualification (education, experience and/or training, required certifications):
Education
- Bachelor’s degree in sciences
- Preferably a degree in pharmaceutical studies (Pharmacist)
- Fluent in English (written & verbal)
- German language skills (minimum B2 level)
Experience
- Demonstrated leadership / influencing skills in a cGxP environment; preferably within a Quality role for a minimum of 5 years
- Ability to both lead and support; and a track record of business, partnering with internal and external stakeholders
- Effective communications (written/verbal), presentation and facilitation skills, including official communication to authorities
- Interpersonal savvy, with the capacity to build strong relationships at a senior level
- Experienced in leading Regulatory Inspection audits and management of HA responses.
- Demonstrated analytical & investigational skills
- Effective organizational and planning skills; managing near term priorities & strategic aspirations
Additional Preferences:
- Fluent in German (written & verbal)
- Knowledge of complex Quality organizations, global Supply Chains and a basic understanding of Product Registration Strategies highly regarded.
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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
