ESO QA Manager

Laboratorio STADA, S.L.; Castilla-La Mancha; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Una empresa farmacéutica internacional de éxito busca un Gerente de Calidad ESO para asegurar la calidad a lo largo de la cadena de suministro. En esta posición, serás responsable de desarrollar la organización de calidad, implementar políticas y gestionar proyectos de mejora continua. Si tienes experiencia en la industria farmacéutica y un fuerte conocimiento de las regulaciones, esta es una excelente oportunidad para unirte a un equipo comprometido con el crecimiento y la innovación. Ofrecemos un entorno competitivo que fomenta el desarrollo personal y profesional en una empresa en expansión llena de oportunidades.

Formación

• 5+ años de experiencia en la industria farmacéutica, especialmente en gestión de CMO.
• Conocimiento sólido de regulaciones de la industria farmacéutica en EE.UU. y UE.

Responsabilidades

• Desarrollar y mejorar continuamente la organización de calidad ESO y las capacidades del equipo.
• Asegurar la implementación de políticas y estándares globales de ESO por parte de los CMO.

Conocimientos

Gestión de Calidad

Conocimiento de regulaciones (EMA, FDA)

Mejora Continua

Gestión de Proyectos

Educación

Grado en Ciencias Farmacéuticas

Máster en Ciencias Farmacéuticas

Descripción del empleo

At STADA we pursue the purpose of "Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision, and values. With our wide range of products: Generics, Consumer Healthcare, and Specialties, we offer patients, doctors, and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility, and One STADA, in order to achieve our ambitious goals and shape a successful future for our company. We continually expand our goals in line with our ambition, and we achieve them with passion, commitment, and a growth mindset.

Do you want to be part of a successful international pharmaceutical company and grow with us?

The ESO QA Manager is the Global process owner for assuring the quality along the supply chain of the products from Stada’s Key Strategic contract manufacturers.

RESPONSIBILITIES

1. Develop and continuously improve the ESO Quality organization and the capabilities of the team.
2. Ensure STADA global ESO Policies and Standards will be implemented by CMOs.
3. Development of cross-functional ESO quality infrastructure to ensure holistic CMO quality management considering Regulatory Compliance, GMP Compliance, and Qualification status.
4. Continuously monitor the quality status of the products supplied by CMOs and initiate Quality improvement projects.
5. Ensure the implementation of Corrective and Preventive Actions (CAPAs) and communicate changes and challenges with suppliers.
6. Competent Authority Preparation activities and support of CMO’s through authority inspections.
7. Establish Quality Performance Reviews with indicators and methods to improve the suppliers’ fulfillment towards requirements and chair the respective meetings.
8. Coordinate the quality section in ESO Business Review with Strategic CMOs.
9. Lead and review continuous improvement projects and prioritize and lead innovation ideas in collaboration with suppliers.

REQUIREMENTS

1. University degree in pharmaceutical science, natural sciences, or related field.
2. Master's degree is an added value.
3. At least 5 years’ experience in the pharmaceutical industry, primarily in the CMO management field.
4. Sound knowledge of the relevant US & EU regulations, EMA, FDA, and other regulatory standards in the pharmaceutical industry.
5. In-depth business knowledge of manufacturing and supply chain operations.

We look forward to receiving your application through our job portal.

STADA offers a competitive environment for personal and professional development in a growing company full of opportunities.