Local Quality Assurance Manager (GDP) IberiaApplylocations: R-21807Title:Local Quality Assurance Manager (GDP) IberiaCompany:Ipsen Pharma SAAbout 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.
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. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. 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. We attract and develop bold, agile, and entrepreneurial people who take full responsibility for their decisions;

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, willact 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. 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;
* 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;
* 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 integral/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;
* Ensures comprehensive training program covering GDP activities;
* 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, audits, mock-recalls and should the situation arise, to participate in Product Recall Management;
* Support local product release activities; Quality interface for local Distribution partners;Collaboration with other Departments* Proactively advocate for quality processes across functions
* Proactively identify areas for process improvement and mediate cooperation cross-functionally to effect and implement the Quality System;
* Contribute towards stakeholder value by providing quality leadership and operational input towards affiliate strategic and tactical activities
* Strengthen the risk management culture and support the update of the IPSEN Risk register;To maintain membership of societies and professional organisations of interest to the company, according to local legislation and the Group's guidance;
*

Requirements:
**Knowledge & Experience (essential):
* Experience in a similar position with a proven experience in
* Maintaining Quality Management System in accordance with GDP and Regulations on Distribution of Medicinal Products.
* Auditing
* Host/Coordinate audits/inspections
* Risk assesment
* Approximately 1-2 years in similar positionKnowledge & Experience (preferred):
* Experie

📌 Local Quality Assurance Manager (España)
🏢 Ipsen Group
📍 España