Overview In this role you ensure the Pharmacovigilance Quality System remains compliant and efficient, guiding audits, inspections, and documentation to support safe medicines. You work with a cross-functional team and external partners to uphold regulatory standards and continuous improvement.

Your impact lies in readiness for inspections, robust audit programs, and alignment of GVP with evolving requirements. This is an opportunity to shape QA in drug safety within a patient-focused dermatology company.

Responsabilidades Maintain the Quality System for Pharmacovigilance in line with Almirall policies, ICH, EU GVP modules, and relevant regulations

Design and manage a risk-based GVP audit plan; coordinate or oversee audits of affiliates, CROs/vendors, and internal audits

Report audit findings to management and ensure closure of significant issues





Lead preparation and management of inspections by Competent Authorities and third-party audits, developing an inspection readiness plan

Review and approve procedures and key documents to ensure compliance with Drug Safety regulations

Select and supervise outsourced QA activities related to pharmacovigilance (audits, mock inspections, training)

Involve in due diligence of development products as needed

Promote continuous improvement of the GVP Quality System based on audit findings and regulatory changes

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

Leadership and people management

Stakeholder management

Attention to detail

Knowledge of GVP, GMP, and GCP

Pharmacovigilance, drug safety, clinical trials

Data management, pharmacokinetics, and statistics

📌 QA SENIOR MANAGER (Barcelona)
🏢 Almirall
📍 Barcelona