We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.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.- 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 CUALIFICADO: 6- HORARIO: Central FlexQA R&D; & CPD - GVP Quality Assurance Senior ManagerSummaryLocation: SANT FELI

📌 Qa Senior Manager (Cataluña)
🏢 Almirall
📍 Cataluña