ESO QA Manager

JR Spain; Torrejón de Ardoz; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Join a leading international pharmaceutical company as an ESO QA Manager. You'll be responsible for assuring quality along the supply chain, implementing global policies, and leading continuous improvement projects. This role requires strong knowledge of regulatory standards and experience in CMO management.

Formación

• At least 5 years’ experience in the pharmaceutical industry, primarily in CMO management.
• Sound knowledge of US & EU regulations, EMA, FDA.

Responsabilidades

• Develop and improve the ESO Quality organization and capabilities.
• Ensure implementation of STADA global ESO Policies and Standards by CMOs.
• Monitor quality status of products supplied by CMOs.

Conocimientos

Quality Management

Regulatory Compliance

Continuous Improvement

Educación

University degree in pharmaceutical science

Master degree

Descripción del empleo

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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

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

REQUIREMENTS

• University degree in pharmaceutical science, natural sciences, or related field.
• Master degree is an added value.
• At least 5 years’ experience in the pharmaceutical industry, primarily in the CMO management field.
• Sound knowledge of the relevant US & EU regulations, EMA, FDA and other regulatory standards in the pharmaceutical industry.
• 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.

Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment.

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