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Head of Product Quality Manufacturing and Testing
il y a 2 heures
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. PURPOSE OF THE FUNCTION Set the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient product delivery. Act as a key enabler across the product lifecycle by partnering with Product Quality leaders, Technical Operations, QLT, and external partners to ensure seamless development-to-commercial transitions. Ensure a high-performing and value-driven product quality vendor network aligned with business and quality strategy. Build trusted, collaborative partnerships internally and externally to proactively manage risk and ensure sustained compliance with the quality strategy REPORTING LINE Global Head of Product Quality ROLES AND RESPONSIBILITIES Provide leadership to build, develop, and sustain a high-performing Manufacturing and Testing Product Quality organization , fostering accountability, engagement, and succession readiness. Define and own the Manufacturing and Testing Product Quality strategy , including operating model, resource strategy, and external partnership approach, aligned with business priorities and global network expansion. Serve as the GMP strategic authority for Manufacturing and Testing Product Quality, providing expert guidance to internal stakeholders to ensure sustained compliance, inspection readiness, and product quality across the lifecycle. Establish and govern the GMP strategy for third-party manufacturers and testing partners , ensuring consistent quality standards, oversight models, and performance expectations across the external network. Drive a culture of continuous improvement, innovation and quality excellence , ensuring systematic identification, prioritization, and execution of improvement opportunities internally and with partners. Own and maintain the Manufacturing and Testing Product Quality framework , including policies, standards, governance, and interfaces with Technical Operations and Product Quality. Define quality and business performance objectives , oversee KPI frameworks, and ensure data-driven decision-making to proactively manage risk and performance across manufacturing processes and analytical systems. Continuously evolve the quality management system and ways of working by leveraging industry best practices, regulatory trends, and stakeholder needs, ensuring scalability and future readiness. SKILLS AND COMPETENCIES Strong strategic and collaborative leadership skills. Ability to lead, motivate and coach the quality teams on quality and key business aspects. Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and external collaborators. Excellent organizational and interpersonal skills. Strong technical mastery, analytical and problem-solving skills. Solid scientific writing and reporting skills in English. Experience with GXP area within a biopharmaceutical company. Good knowledge of FDA, EU and PMDA regulations and ICH Guidelines. Strong quality mind set. Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines. Extensive experience management health authority inspections and in-depth knowledge of FDA and EU regulations and ICH Guidelines. EDUCATION, EXPERIENCE AND QUALIFICATIONS 10y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations. Knowledge of analytical techniques. Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA, … ). At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at #J-18808-Ljbffr
