Descripción de la oferta
## QA SENIOR MANAGERBewerbenremote type: Industrial Operationslocations: SANT FELIU DE LLOBREGAT: SANT ANDREU DE LA BARCA: GLOBALtime type: Full timeposted on: Vor 5 Tagen ausgeschriebentime left to apply: Enddatum: 31. August 2026 (Noch 30+ Tage Zeit für Bewerbung)job requisition id: 001567**Warum Almirall?**Wir gestalten die Zukunft der medizinischen Dermatologie, indem wir uns auf unerfüllte Bedürfnisse von Patient:innen konzentrieren und Menschen den Raum geben, eigenständig zu denken, Verantwortung zu übernehmen und Wirkung zu erzielen, die wirklich zählt.Unser Anspruch ist klar: das Leben von Patient:innen zu verbessern, indem wir auf echte Bedürfnisse eingehen. Wir arbeiten mit Präzision, handeln mutig, halten die Dinge einfach und richten unsere Innovation dort aus, wo sie wirklich einen Unterschied macht.Als Top Employer in Spanien seit 2008 und in Deutschland seit 2025 investieren wir kontinuierlich in ein Umfeld, in dem Menschen wachsen und vorankommen können.Wenn du Dinge anders angehst, bist du hier richtig.**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.- 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
