Local Quality Assurance Manager

Local Quality Assurance Manager (GDP) Iberia

Title:

About Ipsen:

Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human‑centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society

At Ipsen, we believe that patients cannot wait to receive the right treatment, support, and awareness they need. Therefore, our goal is to make a difference by significantly improving the health and quality of life of patients and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

The patient is at the center of everything we do, and we also care about our employees because they are the ambassadors and the ones who truly make a difference. We attract and develop bold, agile, and entrepreneurial people who take full responsibility for their decisions; leaders drawn to the purpose of making a direct impact through their work on people’s lives.

We offer employees a wealth of rewarding challenges and growth opportunities, and the chance to contribute within a constantly moving organization, an organization that truly changes the game.

At Ipsen, we are looking for a Local Quality Assurance Manager (GDP) Iberia , based in Barcelona, who, under the direction of the Quality Lead Iberia, will

act as the Quality Assurance Manager function at Ipsen Commercial Operations Iberia (Spain & Portugal) for Good Distribution Practices (GDP) activities.

The Quality Assurance Manager is responsible for the overall management of the Affiliate Quality Management System and quality assurance programs, to foster a strong quality and continuous improvement culture, and thus ensuring that the local license to operate activities meet internal and external requirements (including regulations and Good x Practices), policies and procedures.

Your main responsibilities will include:

Quality Assurance

• Act as the local quality assurance/quality system representative for the Iberian cluster;
• Establish and maintain Iberian cluster Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements;
• Host/Coordinate audits/inspections on behalf of GDP functions within the Iberian cluster;
• Local supplier assessment and oversight including QTAs maintenance and local audits conduct;
• Ensure Quality management review and KPIs are established;
• Maintain quality assurance activities for GDP programs/activities;
• Focuses on proactive crisis prevention and supports crisis (QSEB) and CAPA follow‑up when needed;
• Drive and support local and global initiatives on continuous quality improvement;
• Drives remediation plan when a product quality or GxP process issue is identified;
• As Product Quality Complaint Manager Iberia, maintain and ensure local Product Complaints and recalls management;
• To control, in conjunction with local distributor(s), the reception, warehousing and distribution of the Ipsen products;
• To ensure that distributors comply with Good Distribution Practices (in particular cold chain and transportation);
• Integrate global/corporate and Iberian cluster, as applicable, quality needs and priorities, including representing the Affiliate at the Ipsen Global Quality Forum;
• Foster quality culture by encouraging best practices and a high performing “quality beyond compliance” culture, both from procedural and patient/customer centricity perspectives;
• Contribute strongly to building quality and compliance through governance and education;
• Participate on regulatory intelligence process and, where necessary, elevate with technical expertise, assessment and solution proposals;
• Ensures comprehensive training program covering GDP activities;
• Ensure the Iberian cluster, self‑inspection, GDP audit readiness; business continuity, change control, Deviations and CAPA management systems and activities are in place and implemented to cover GDP processes;
• Conduct and/or host risk assessments, self‑inspections, regulatory inspections,