QA SENIOR MANAGER

Almirall, S.A; Sant Feliu de Llobregat, Sant Andreu de la Barca; On-site; EUR 70,000 - 110,000; Full time

Job summary

Almirall, S.A in Sant Feliu de Llobregat is seeking a QA Senior Manager to maintain and improve the GVP Quality Management System, ensuring compliance with ICH, EU GVP modules, and pharmacovigilance regulations.

You will lead audits, inspections, and QA activities with internal and external partners, fostering continuous improvement while coordinating with safety teams. Fluent English and strong regulatory expertise are required.

Qualifications

• Knowledge of GVPs, GMPs and GCPs, drug safety and clinical trials.
• Regulatory requirements for EU and non-EU pharmacovigilance.
• Training in Quality Assurance, especially in R&D areas.
• Proficiency in English.

Responsibilities

• Maintain the PhV quality system in line with ICH, EU GVP modules and Almirall policies.
• Set up risk-based GVP audit plans and audits across affiliates, partners, CROs and vendors.
• Report audit observations to management and close significant findings.
• Lead inspection readiness and manage inspections by authorities.
• Edit and approve procedures ensuring alignment with drug safety regulations.
• Oversee outsourced QA activities for pharmacovigilance.
• Involve in due diligence for development products as needed.
• Champion continuous improvement of the GVP Quality System.

Skills

GVP/GMP/GCP knowledge

Drug safety

Clinical trials

Data management

Pharmacokinetics

Statistics

EU/non-EU regulatory knowledge

Quality Assurance training

English proficiency

Education

Life science degree (Pharmacy, Chemistry, Biology, etc.)

Job description

## QA SENIOR MANAGERPresenta candidaturaremote type: Industrial Operationslocations: SANT FELIU DE LLOBREGAT: SANT ANDREU DE LA BARCA: GLOBALtime type: Full timeposted on: Offerta pubblicata 3 giorni fatime left to apply: Data fine: 31 agosto 2026 (30+ giorni rimanenti per candidarsi)job requisition id: 001567Stiamo costruendo il futuro della dermatologia medica concentrandoci sui bisogni ancora insoddisfatti dei pazienti e dando alle persone lo spazio per pensare in modo indipendente, assumersi responsabilità e generare un impatto che conta davvero.Il nostro purpose è semplice: trasformare la vita dei pazienti rispondendo a bisogni reali. Lavoriamo con rigore, agiamo con coraggio, teniamo le cose semplici e orientiamo l’innovazione dove può davvero fare la differenza.Riconosciuti come Top Employer in Spagna dal 2008 e in Germania dal 2025, continuiamo a investire in un ambiente in cui le persone possono crescere e andare avanti.Se pensi in modo diverso, qui è il posto giusto per te.**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