Quality and Regulatory Director
hace 1 semana
Job Title: Quality and Regulatory Director Los candidatos deben tomarse el tiempo de leer atentamente todos los elementos de este anuncio de empleo. Por favor, envíen su solicitud sin demora. Location: Paterna, Spain Reports to: Chief Operating Officer (COO) Department: Quality / Senior Leadership Team Position Overview: We are seeking a highly experienced Quality and Regulatory Director to lead our Quality Control, Quality Assurance, and Regulatory Affairs functions. As a senior leader, you will shape and execute the company's quality and regulatory strategy, ensuring operations and products meet all GxP standards and regulatory requirements. You will be instrumental in preparing for FDA inspections, including a Pre-Approval Inspection (PAI) in 2026 , and in implementing and maintaining eQMS and LIMS systems in full compliance with regulatory standards. Key Responsibilities: Lead regulatory strategies to ensure compliance with FDA, EMA, ISO, and ICH guidelines. Act as a subject matter expert for regulatory affairs, including approvals for API, drug products, and novel excipients. Prepare the organization for FDA PAI inspections and act as Qualified Person for batch certification and release. Lead implementation, validation, and oversight of eQMS and LIMS systems. Drive internal audits, gap assessments, and CAPA processes, ensuring inspection readiness. Oversee Quality Control and Quality Assurance teams, ensuring products meet all quality standards. Prepare and submit regulatory filings (INDs, NDAs, BLAs, CTDs, DMFs) and interpret regulatory feedback. Collaborate with cross-functional teams to ensure regulatory compliance throughout product development. Lead, mentor, and develop Quality and Regulatory teams, fostering high performance and professional growth. Build and maintain strong relationships with customers and regulatory agencies. Establish risk management strategies related to regulatory and quality compliance. Drive operational excellence, process improvements, and efficiency in regulatory operations. Qualifications & Experience: Bachelor's degree in Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or related field; Master's or MBA preferred. Minimum 7 years of experience in quality and regulatory affairs within the pharmaceutical or CDMO sector. Proven track record of leading regulatory approvals for API, drug products, and novel excipients. Strong expertise in FDA/EMA regulations, GxP standards, and eQMS/LIMS implementation and validation. Experience preparing for FDA inspections, particularly Pre-Approval Inspections (PAI). Extensive experience in regulatory submissions (INDs, NDAs, CTDs, DMFs, BLAs) for chemical and biologic products. Demonstrated leadership in cross-functional teams, with the ability to recruit, motivate, and develop high-performing teams. Strong stakeholder management and relationship-building skills with regulatory agencies and customers. Fluent in English; Spanish working proficiency preferred. xsgfvud Excellent problem-solving, analytical, organizational, and strategic thinking skills.
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Quality and Regulatory Director
hace 1 semana
Chiva, España ARTO A tiempo completoJob Title: Quality and Regulatory DirectorA continuación se detalla todo lo que necesita saber sobre lo que implica esta oportunidad, así como lo que se espera de los solicitantes.Location: Paterna, SpainReports to: Chief Operating Officer (COO)Department: Quality / Senior Leadership TeamPosition Overview:We are seeking a highly experienced Quality and...
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Quality and Regulatory Director
hace 5 días
Chiva, España ARTO A tiempo completoJob Title: Quality and Regulatory Director Se anima a todos los posibles solicitantes a que se desplacen y lean la descripción completa del puesto antes de presentar su candidatura. Location: Paterna, Spain Reports to: Chief Operating Officer (COO) Department: Quality / Senior Leadership Team Position Overview: We are seeking a highly experienced Quality...
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Global Head of Quality, Industry BU
hace 2 semanas
Chiva, España medmix A tiempo completoCompany Description Desplácese hacia abajo para obtener una visión general completa de lo que requerirá este trabajo. ¿Es usted el candidato adecuado para esta oportunidad? medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our...
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Global Head of Quality, Industry BU
hace 2 semanas
Chiva, España medmix A tiempo completoCompany Description Desplácese hacia abajo para obtener una visión general completa de lo que requerirá este trabajo. ¿Es usted el candidato adecuado para esta oportunidad? medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our...
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Laboratory Analyst H/M
hace 3 días
Chiva, España Recover A tiempo completoAbout our CompanyPor favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de interés.RecoverTM is a leading materials science company and global producer of low-impact, high-quality recycled cotton fiber and cotton fiber blends.We enable large-scale sustainable change in fashion through business value &...
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Técnico de Laboratorio Textil
hace 3 días
Chiva, España Recover A tiempo completoAbout our Company ¿Tiene su CV preparado? Si es así y confía en que este es el puesto ideal para usted, asegúrese de enviar su solicitud lo antes posible. RecoverTM is a leading materials science company and global producer of low-impact, high-quality recycled cotton fiber and cotton fiber blends. Our purpose We enable large-scale sustainable change in...
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Técnico de Laboratorio Textil
hace 2 días
Chiva, España Recover A tiempo completoAbout our Company Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas. RecoverTM is a leading materials science company and global producer of low-impact, high-quality recycled cotton fiber and cotton fiber blends. Our purpose We enable large-scale sustainable...
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Qa Lead
hace 2 semanas
Chiva, España medmix A tiempo completoCompany DescriptionSi los siguientes requisitos del puesto y la experiencia coinciden con sus habilidades, por favor, asegúrese de enviar su solicitud sin demora.medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our 14 production sites worldwide, together with...
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QA Testing Lead
hace 2 semanas
Chiva, España medmix A tiempo completoCompany DescriptionSi los siguientes requisitos del puesto y la experiencia coinciden con sus habilidades, por favor, asegúrese de enviar su solicitud sin demora.medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our 14 production sites worldwide, together with...
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Data and AI Scientist and Analyst
hace 1 semana
Chiva, España Avincis A tiempo completoAvincis is one of the world's leading Emergency Aerial Service Operators and the largest in Europe. Join us and be part of a mission to protect lives, safeguard communities, and make a positive impact.We are seeking a skilled and motivated Data and AI Scientist to join our team. Reporting to the Head of Data and AI, this role will support either the COO &...
