QA Contract Manufacturing Senior Manager

Almirall Hermal GmbH; País Vasco; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Una empresa innovadora busca un Gerente Senior de Fabricación por Contrato en Aseguramiento de Calidad. En esta función crucial, serás responsable de garantizar la excelencia en la gestión de calidad de productos farmacéuticos y biopharma fabricados externamente. Te encargarás de liderar auditorías, mejorar sistemas de calidad y proporcionar experiencia técnica para resolver problemas complejos. Si tienes una sólida experiencia en gestión de calidad y habilidades de comunicación en inglés y español, esta es tu oportunidad para marcar la diferencia en un entorno dinámico y colaborativo.

Formación

• 8-10+ años de experiencia en gestión de calidad externa de productos farmacéuticos.
• Conocimientos profundos en sistemas de calidad y requisitos regulatorios internacionales.

Responsabilidades

• Asegurar la excelencia en la gestión de calidad de CMOs y el sistema de gestión de calidad.
• Planificar y ejecutar auditorías como auditor líder para CMOs de fabricación de Biológicos.

Conocimientos

Gestión de Calidad

Comunicación en Inglés

Conocimiento de GXP

Gestión de Cambios

Negociación en Entornos Complejos

Educación

Título universitario en Ciencias de la Vida

Formación adicional en biotecnología

Descripción del empleo

QA Contract Manufacturing Senior Manager Mission

Ensure excellence in Quality Assurance (QA) management of Contract Manufacturing Organizations (CMOs) and the associated Quality Management System (QMS) for commercial Pharmaceutical and Biopharmaceutical drug products manufactured and supplied by external sites.

Functions and key aspects of the role:

• Excellence in QA management of partnerships and CMOs manufacturing Pharma and Biopharma products acting as key QA contact with CMOs and QA Contract Manufacturing representative in cross-functional projects.
• Leadership of the management and improvement of Almirall QMS for external operations on commercial pharma and biopharma products ensuring that needs of commercial production are met and aligns with applicable regulatory standards.
• Provides technical expertise to solve complex quality issues, support manufacturing, QC & QA processes in CMOs and drive continuous improvement initiatives.
• Plan and execute audits acting as Lead Auditor for GMP audits to CMOs, including Biologics manufacturing sites and related supplies/services.
• Is involved and manage QA aspects of transfer projects for Pharmaceutical and Biologics and ensure integration into the existing QMS.
• Support as QA expert/SME role in evaluation of Business Development opportunities for commercial pharma products and biologics and support decision-making processes with technical expertise, as requested.
• Act as a training and knowledge reference within QA CM Team on commercial Biologics.

Required profile

Education:

• University degree in Life Science related field. Biotechnology background or additional training in biotechnology highly valuable.

Specific expertise:

• 8-10+ years related experience in external quality management of pharmaceutical/biopharmaceutical products.
• Deep knowledge and direct expertise on Manufacturing/QC/QA & Change Management of commercial Biologics (Drug Substance & Drug Product) is essential.
• Technical working proficiency in quality systems with strong knowledge of GXP and international Regulatory requirements (e.g. EU, FDA, ICH).
• Oral and written communication skills in English are essential.
• Global business environment knowledge and expertise in dealing and negotiation in complex business situations are essential.
• Knowledge on devices for biologics (e.g., combination product) will be considered an advantage.

Languages:

• Advanced written and verbal communication skills in English and Spanish are essential.

Corporate Values

• Care: we listen & empathize. We value diverse perspectives & backgrounds and we help each other succeed.
• Courage: we challenge the status quo. We take full ownership and we learn from our success & failures.
• Innovation: we put the patient and customer at the center. We create novel solutions and we empower entrepreneurial mindsets.
• Simplicity: we act decisively and avoid over-analysis. We understand why before we act and we are agile & keep things simple.