Quality Manager, Elanco GmbH (m/f/d) - zunächst befristet im Rahmen einer Elternzeitvertretung

☞ Elanco

Ver: 177

Día de actualización: 22-10-2024

Ubicación: Bad Homburg Hesse

Categoría: Seguro de Calidad / Control de Calidad

Industria: Pharmaceutical Manufacturing

Posición: Mid-Senior level

Tipo de empleo: Full-time

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Contenido de trabajo

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Position Description:

As the central quality contact for the Elanco GmbH 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, Task:

Ensure that all operations of Elanco 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 distributors.
  • Support other nominated responsible person(s) to fulfill their legal obligations. Examples include Responsible person according to
  • 37 German Veterinary Vaccines Regulation
  • 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 by the respective importing sites (eg KVP), so that all products are imported into Germany in compliance with EU 2019/6, comply to their specification and are distributed in compliance with the specified conditions.
  • Ensure a process is in place to maintain “right product/right country” for shipments under the responsibility of Elanco GmbH
  • 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. This will include chairing the local recall committee.
  • Manage agency inspections related to GDP/ GMP activities
  • 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.
  • Perform any other duties or serve in such other capacity as may be determined by Company management.

Minimum Qualification (education, experience and/or training, required certifications):

Education:
  • Bachelor degree in sciences
  • Person has to meet the requirements to fulfil the pharmaceutical duties as a Quality Responsible person

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
  • 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 English and German (written & verbal)
  • Inventory management knowledge highly regarded.

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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Plazo: 06-12-2024

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