QA SENIOR MANAGER
21 hours ago
Sant Feliu de Llobregat
QA SENIOR MANAGERSolicitarremote type: Industrial Operationslocations: SANT FELIU DE LLOBREGAT: SANT ANDREU DE LA BARCA: GLOBALtime type: Full timeposted on: Publicado hace 5 díastime left to apply: Fecha final: 31 de agosto de 2026 (Quedan más de 30 días para realizar la solicitud)job requisition id: 001567Estamos 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.Nuestro propósito es sencillo: transformar la vida de los pacientes abordando necesidades reales. Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas. Trabajamos con rigor, actuamos con valentía, simplificamos lo complejo y enfocamos la innovación allí donde realmente marca la diferencia.Reconocidos como Top Employer en España desde 2008 y en Alemania desde 2025, seguimos invirtiendo en un entorno donde las personas pueden crecer y avanzar.Si quieres hacer las cosas de otra manera, este es tu lugar. **Mission **Responsible for the maintenance, development and continuous improvement of the Almirall GVP Quality Management System ensuring compliance with applicable regulations and guidelines. **Functions and responsibilities 1. 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. **2. 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. **3. To report the observations arising from audits (or any other quality issue) to applicable management and follow-up on the significant findings until completion. **4. To lead the preparation and management of inspection by Competent Authorities and audits by third parties to Almirall by developing an inspection readiness plan. **5. To edit, review and approve the procedures and any other key documents ensuring that they are aligned and compliant with the applicable regulation applicable to Drug Safety. **6. To select, coordinate and oversee the outsourced QA activities applicable to pharmacovigilance (e.g. audits, mock inspections, training). **7. Involvement in due diligence of development products, as needed. **8. To promote the continuous improvement of the GVP Quality System based on audit findings and changes in regulatory requirements. **Education **Life science degree (Pharmacy, Chemistry, Biology, etc.) **Specific expertise - Knowledge of GVP's, GMP's and GCP's, drug safety, clinical trials, data management, pharmacokinetics, and statistics.- EU and non-EU regulations applicable to pharmacovigilance. xcskxlj - Training in Quality Assurance, specifically R&D areas.- Proficiency in English languageINFORMACIÓN ADICIONAL- CENTRO DE TRABAJO: R&D • SANT FELIU DE LLOBREGAT- TIPO DE CONTRATO: Indefinido- GRUPO PROFESIONAL: 6- HORARIO: Central FlexQA R&D & CPD, • GVP Quality Assurance Senior Manager #J-18808-Ljbffr
