ESO QA Manager

STADA Arzneimittel AG; Barcelona; Presencial; EUR 45.000 - 80.000; Jornada completa

Descripción de la vacante

Join a forward-thinking international pharmaceutical company as an ESO QA Manager, where you will be the global process owner for quality assurance across the supply chain. This role focuses on developing a robust quality organization, ensuring compliance with regulatory standards, and leading improvement initiatives. You'll work closely with strategic contract manufacturers to enhance product quality and drive innovation. If you are passionate about quality management and eager to contribute to a company dedicated to health and well-being, this opportunity is perfect for you.

Formación

• 5+ years of experience in the pharmaceutical industry, mainly in CMO management.
• Sound knowledge of US & EU regulations in the pharmaceutical industry.

Responsabilidades

• Develop and improve the ESO Quality organization and team capabilities.
• Ensure implementation of global ESO Policies and Standards by CMOs.
• Lead and review continuous improvement projects with suppliers.

Conocimientos

Quality Management

Regulatory Compliance

GMP Compliance

Project Management

Cross-Functional Collaboration

Educación

University degree in pharmaceutical science

Master degree

Descripción del empleo

ABOUT US

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?

POSITION SUMMARY

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’ fulfilment towards requirements and chair the respective meetings.
8. Coordinate the quality section in ESO Business Review with Strategic CMO‘s.
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 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.