Head of Product Quality Manufacturing and Testing

Head of Product Quality Manufacturing and Testing

argenx

Ghent, Belgium

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, … ).