Local Quality Assurance Manager (GDP) Iberia

Job description

Title: Local Quality Assurance Manager (GDP) Iberia Company: Ipsen Pharma SA 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! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: 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, escalate 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, audits, mock-recalls and should the situation arise, to participate in Product Recall Management; Support local product release activities; Facilitate troubleshooting; support any OOS, if applicable; 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; Communication To respect and apply the company rules (especially the confidentiality ones) and strategy in communication with media, authorities and health professionals; To maintain membership of societies and professional organisations of interest to the company, according to local legislation and the Group’s guidance; To act with all relevant authorities/entities, with a great sense of public relations, having in perspective an increased efficiency and recognition of Ipsen; To maintain and develop positive and ethical interactions with relevant authorities; To respect and apply the IPSEN ethical code Who are we looking for? 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 position Knowledge & Experience (preferred): 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 2-3 years in similar position Education / Certifications (essential): Degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences) with accredited training on GDPs Education / Certifications (preferred): Master in Pharmaceutical Industry and Postgraduation in Quality, Pharmacovigilance and Regulatory Affairs of the Pharma Industry Language(s) (essential): Expert/fluent communicator in Spanish and English. Language(s) (preferred): Expert/fluent communicator in Portuguese and English. Knowledge of Portuguese is a valuable asset Competencies: Drive Purpose: Puts values and ethics at the forefront of everything; Anchors Ipsen's purpose, mission and commitments to patients and society. Manage Complexity: Identifies contradictory information/demands/inputs to effectively solve problems; Develops and evaluates alternative scenario and solutions; Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact. Mindfulness Risk-taking: Methodically assesses, transparently shares, and makes risk-informed decisions; Empowers to take ownership and accountability. Excellence i