Quality Assurance Laboratory Manager

Grifols; Sant Cugat del Vallès; Híbrido; EUR 70.000 - 90.000; Jornada completa

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Descripción de la vacante

Grifols busca un profesional para liderar el control de calidad en laboratorios de pruebas plasmáticas, asegurando cumplimiento con cGMP y gestionando proyectos de calidad en un entorno global.

Se requieren experiencia en entornos regulados, habilidades para comunicar y coordinar mejoras, dominio del español e inglés y disponibilidad para viajar, con presencia en Egipto en aproximadamente la mitad del tiempo.

Formación

• Bachelor’s Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields).
• Minimum 3–5 years of experience in a related field.
• Advanced level of Spanish and English.
• This position requires significant travel and on-site presence in Egypt, with approximately 50% of the role based in Egypt.

Responsabilidades

• Review procedures to ensure compliance with cGMP.
• Supervise GEPD Plasma Testing Laboratories quality system and quality culture.
• Ensure investigations for incidents include root cause analysis.
• Support internal and external regulatory inspections and audits.
• Manage and supervise Plasma Testing Laboratories Quality projects.
• Coordinate tasks across different areas of the company.
• Review new procedures and processes under Change Controls.
• Monitor and improve quality system indicators.
• Supervise the Quality Risk Management (QRM) process and risk assessments.

Conocimientos

Organizational skills

Regulatory experience

SOP understanding

Planning & communication

Integrity & Compliance

Communication skills

Spanish/English bilingual

Travel willingness

Educación

Bachelor’s Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields)

Descripción del empleo

¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.

Mission

To review and ensure that all procedures, testing methods and reports established in GEPD Plasma Testing Laboratories are in compliance to Egyptian regulations, and in accordance to cGMP, following Plasma Testing Specifications established and European Regulation. To manage and supervise Plasma Testing Laboratories Quality projects. To propose continuous improvement measures related to the quality systems of the Laboratories. To supervise the Quality Risk Management (QRM) process for the Laboratories.

What Your Responsibilities Will Be

• To review and ensure that all procedures established are in accordance to cGMP.
• To supervise GEPD Plasma Testing Laboratories quality system and quality culture.
• To ensure investigation for incidents are initiated, as well as root cause analysis are properly in place.
• To participate and support internal and external regulatory inspections and audits performed in the Laboratories.
• To manage and supervise Plasma Testing Laboratories Quality projects.
• Actively participate in Laboratory meetings for the follow-up of activities related to open Change Controls.
• Coordinate the tasks required to be developed within the different areas of the company.
• Review new procedures and processes to be implemented in the Laboratory under the scope of the Change Controls open.
• To ensure continuous improvement measures related to the quality systems of the Laboratories.
• To supervise the monitoring of corrective and/or preventive actions implemented within the Laboratories. Ensure their proper implementation and effectiveness.
• To monitor quality system indicators.
• To propose improvements in the Laboratory's processes to enhance the quality system.
• To supervise the Quality Risk Management (QRM) process for the Laboratories.
• To supervise Quality Risk assessment studies and reports, as well as coordinate mitigation tasks.

Who You Are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• Bachelor’s Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields)
• Minimum 3-5 years of experience in a related field.
• Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor intensive environment.
• Ability to understand, explain, follow, and enforce SOPs.
• Ability to plan, communicate and execute activities for the improvement of overall operations.
• Strong integrity and commitment to Quality and Compliance.
• Excellent oral and written communication skills to produce clear and concise factual findings.
• Advanced level of Spanish and English.
• This position requires significant travel and on-site presence in Egypt, with approximately 50% of the role based in Egypt.

What We Offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available at www.grifols.com.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexibility for U Program

Occasionally Remote.

Benefits Package

Contract of Employment: Permanent position.

Location

Location: Sant Cugat del Vallès.

Ubicación: SPAIN : España : Sant Cugat del Valles:[[cust_building]]

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