Healthcare Quality & Compliance Lead — Flexible Hours

Tamarind Intelligence Group; Badalona; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

Grifols, empresa global del sector de la salud, busca un líder de Calidad y Cumplimiento para revisar procedimientos, supervisar el laboratorio de pruebas de plasma y coordinar mejoras del sistema de calidad. Se exige experiencia en entornos regulados, dominio de SOPs y habilidades de comunicación en español e inglés.

La posición requiere presencia en España, con viajes y una distribución de trabajo que incluye Egipto, en un entorno internacional y con posibilidad de trabajo remoto ocasional

Qualifications

• Licenciatura en Ciencias de la Vida (Biología, Farmacia, Biotecnología o afines).
• Experiencia de 3-5 años en un campo relacionado.
• Organización y gestión del tiempo de forma efectiva.
• Capacidad para trabajar en un entorno altamente regulado.
• Capacidad de entender, explicar, seguir y hacer cumplir SOPs.
• Planificar, comunicar y ejecutar actividades para mejorar operaciones.
• Gran integridad y compromiso con la calidad y cumplimiento.
• Excelentes habilidades de comunicación oral y escrita.
• Nivel avanzado de español e inglés.
• Este puesto requiere viajar y presencia en sitio, con aproximadamente el 50% de la labor en Egipto.

Responsibilities

• Revisar y asegurar que todos los procedimientos estén conforme a cGMP.
• Supervisar el sistema de calidad y la cultura de calidad del laboratorio de pruebas de Plasma.
• Investigar incidentes, realizar análisis de causa raíz y seguir acciones correctivas/preventivas.
• Participar y apoyar inspecciones y auditorías regulatorias internas y externas.
• Gestionar y supervisar proyectos de calidad del laboratorio de pruebas de plasma.
• Coordinar reuniones y seguimiento de cambios abiertos en las áreas de la empresa.
• Revisar y aplicar nuevos procedimientos en el laboratorio bajo el alcance de cambios abiertos.
• Supervisar las acciones de mejora de los sistemas de calidad.

Job description

Ofertas de Healthcare Quality Compliance Lead ...

¿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 If you are interested in joining our company and you have what it takes for such an exciting position, then don\'t hesitate to apply!
We look forward to receiving your application!
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: Sant Cugat del Vallès.
SPAIN : España : Sant Cugat del Valles : ((cust_building))
Conoce más sobre Grifols ( ID:
Type: Indefinido tiempo completo
Job Category: Inventory Control & Quality Assurance Area Manager