QA SENIOR MANAGER (España)

QA SENIOR MANAGER (España)

13 ago
|
ALMIRALL
|
España

13 ago

ALMIRALL

España

QA SENIOR MANAGERSolicitarremote type: Industrial Operationslocations: SANT FELIU DE LLOBREGAT: Fecha final: 31 de agosto de 2026 (Quedan más de 30 días para realizar la solicitud)job requisition id: Estamos construyendo el futuro de la dermatología médica centrándonos en las necesidades no cubiertas de los pacientes y dando a las personas el espacio para pensar de forma independiente, asumir responsabilidades y generar un impacto que de verdad importe.Trabajamos con rigor, actuamos con valentía, simplificamos lo complejo y enfocamos la innovación allí donde realmente marca la diferencia.MissionResponsible for the maintenance, development and continuous improvement of the Almirall GVP Quality Management System ensuring compliance with applicable regulations and guidelines.To maintain the Quality System for Pharmacovigilance activities in accordance with Almirall policies, ICH guidelines, EU GVP modules,



and other relevant regulatory requirements with the support of the Almirall Corporate Patient Safety department.To set up the GVP risk-based audit plan and program and perform (or coordinate and oversee when outsourced) audits at affiliates, partners, CROs/vendors as well as internal audits to the Almirall Pharmacovigilance System on a regular basis.To report the observations arising from audits (or any other quality issue) to applicable management and follow-up on the significant findings until completion.To lead the preparation and management of inspection by Competent Authorities and audits by third parties to Almirall by developing an inspection readiness plan.To select, coordinate and oversee the outsourced QA activities applicable to pharmacovigilance (e.g. audits, mock inspections, training).To promote the continuous improvement of the GVP Quality System based on audit findings and changes in regulatory requirements.Specific expertise- Knowledge of GVP's, GMP's and GCP's, drug safety, clinical trials, data management, pharmacokinetics, and statistics.- Trainin

📌 QA SENIOR MANAGER (España)
🏢 ALMIRALL
📍 España

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