PpJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. ArgGenX 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. /p pWe 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. /p h3PURPOSE OF THE FUNCTION /h3 ul liSet the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient product delivery. /li liAct 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. /li liEnsure a high‑performing and value‑driven product quality vendor network aligned with business and quality strategy. /li liBuild trusted, collaborative partnerships internally and externally to proactively manage risk and ensure sustained compliance with the quality strategy. /li /ul h3REPORTING LINE /h3 ul liGlobal Head of Product Quality /li /ul h3ROLES AND RESPONSIBILITIES /h3 ul liProvide leadership to build, develop, and sustain a high‑performing Manufacturing and Testing Product Quality organization, fostering accountability, engagement, and succession readiness. /li liDefine 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. /li liServe 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. /li liEstablish 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. /li liDrive a culture of continuous improvement, innovation and quality excellence, ensuring systematic identification, prioritization, and execution of improvement opportunities internally and with partners. /li liOwn and maintain the Manufacturing and Testing Product Quality framework, including policies, standards, governance, and interfaces with Technical Operations and Product Quality. /li liDefine 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. /li liContinuously evolve the quality management system and ways of working by leveraging industry best practices, regulatory trends, and stakeholder needs, ensuring scalability and future readiness. /li /ul h3SKILLS AND COMPETENCIES /h3 ul liStrong strategic and collaborative leadership skills. /li liAbility to lead, motivate, and coach the quality teams on quality and key business aspects. /li liExcellent relationship management skills with the ability to engage, negotiate, and manage key stakeholders and external collaborators. /li liExcellent organizational and interpersonal skills. /li liStrong technical mastery, analytical and problem‑solving skills. /li liSolid scientific writing and reporting skills in English. /li liExperience with GXP area within a biopharmaceutical company. /li liGood knowledge of FDA, EU and PMDA regulations and ICH Guidelines. /li liStrong quality mind set. /li liAble to operate in a dynamic surrounding of a fast‑growing biotech company with challenging timelines. /li liExtensive experience managing health authority inspections and in‑depth knowledge of FDA and EU regulations and ICH Guidelines. /li /ul h3EDUCATION, EXPERIENCE AND QUALIFICATIONS /h3 ul li10y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations. /li liKnowledge of analytical techniques. /li liExperience with audits and preparation of regulatory inspections (FDA, EMA, PMDA, …). /li /ul pAt 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. /p /p #J-18808-Ljbffr