PURPOSE OF THE FUNCTION
1. Set the strategic direction and vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient product delivery.
2. 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.
3. Ensure a high-performing and value-driven product quality vendor network aligned with business and quality strategy.
4. Build trusted, collaborative partnerships internally and externally to proactively manage risk and ensure sustained compliance with the quality strategy
REPORTING LINE
5. Global Head of Product Quality
ROLES AND RESPONSIBILITIES
6. Provide leadership to build, develop, and sustain a high-performing Manufacturing and Testing Product Quality organization, fostering accountability, engagement, and succession readiness.
7. 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.
8. 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.
9. 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.
10. Drive a culture of continuous improvement, innovation and quality excellence, ensuring systematic identification, prioritization, and execution of improvement opportunities internally and with partners.
11. Own and maintain the Manufacturing and Testing Product Quality framework, including policies, standards, governance, and interfaces with Technical Operations and Product Quality.
12. 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.
13. 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
14. Strong strategic and collaborative leadership skills.
15. Ability to lead, motivate and coach the quality teams on quality and key business aspects.
16. Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and external collaborators.
17. Excellent organizational and interpersonal skills.
18. Strong technical mastery, analytical and problem-solving skills .
19. Solid scientific writing and reporting skills in English.
20. Experience with GXP area within a biopharmaceutical company.
21. Good knowledge of FDA, EU and PMDA regulations and ICH Guidelines.
22. Strong quality mind set.
23. Able to operate in a dynamic surrounding of a fast-growing biotech company with challenging timelines.
24. Extensive experience management health authority inspections and in-depth knowledge of FDA and EU regulations and ICH Guidelines.
EDUCATION, EXPERIENCE AND QUALIFICATIONS
25. 10y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations.
26. Knowledge of analytical techniques.
27. Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA, … ).
#LI-Onsite
The annual base salary hiring range for this position is €100,000.00 - €137,500.00 EUR
This job is eligible to participate in our short-term and long-term incentives program.
The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.