Local Quality Assurance Manager (GDP) Iberia

Local Quality Assurance Manager (GDP) Iberia

Company: Ipsen Pharma SA

Job Description

Based in Barcelona, this role reports to the Quality Lead Iberia and serves as the local Quality Assurance Manager for Good Distribution Practices (GDP) across Ipsen Commercial Operations Iberia (Spain & Portugal).

Responsibilities

• Act as the local quality assurance/quality system representative for the Iberian cluster and lead the establishment and maintenance of the Iberian cluster Quality Management System and Quality Assurance activities, ensuring compliance with all regulatory and GxP requirements.
• Host, coordinate and support audits and inspections for GDP functions within the Iberian cluster, including local supplier assessments, QTAs maintenance, and local audits.
• Develop and maintain quality management review processes, establish KPIs, and provide reporting on key performance indicators.
• Maintain quality assurance activities for GDP programs/activities, focusing on crisis prevention, CAPA follow‑up, and continuous quality improvement initiatives.
• As Product Quality Complaint Manager Iberia, handle local product complaints and recall management, work with distributors to control the reception, warehousing, and distribution of Ipsen products, and ensure compliance with Good Distribution Practices, especially cold chain and transportation.
• Represent the Affiliate at the Ipsen Global Quality Forum and integrate global/corporate and Iberian cluster quality needs and priorities.
• Drive remediation plans for product quality or GxP process issues, support local product release activities, facilitate troubleshooting, and manage OOS when applicable.
• Conduct risk assessments, self‑inspections, regulatory inspections, audits, mock‑recalls, and participate in product recall management as needed.
• Collaborate across functions to advocate for quality processes, identify improvement areas, and mediate cross‑functional cooperation.
• Support risk management culture, update the IPSEN risk register, and maintain business continuity, change control, deviations, and CAPA management systems for GDP processes.
• Communicate appropriately with media, authorities, and health professionals, maintain membership in relevant professional societies, and adhere to the IPSEN ethical code.

Qualifications

• Essential: Minimum 1-2 years of experience in a similar role managing a Quality Management System in accordance with GDP and distribution regulations, including audit hosting/coordination and risk assessment.
• Preferred: 2-3 years of similar experience, Master’s degree in Pharmaceutical Industry or postgraduate qualification in Quality, Pharmacovigilance and Regulatory Affairs.
• Education: Degree in a scientific discipline (Pharmacy, Chemistry, Biological Sciences) with accredited training on GDPs.
• Linguistic requirements: Expert/fluent communication in Spanish and English. Knowledge of Portuguese is a valuable asset.
• Competencies: Drive purpose, manage complexity, mindfulness risk‑taking, excellence in execution, and commitment to best practice sharing.

Benefits & Contract

• Permanent – Full‑time contract, competitive remuneration based on internal equality, external competitiveness, and recognition.
• Flexible working hours model, training and development programmes, and social benefits.
• Commitment to inclusion, equal opportunities, and a workplace where diverse perspectives are valued.