PURPOSE OF THE FUNCTION:
1. Clear Leadership and Vision: Lead and drive the Commercial and Batch Disposition team to align with and achieve argenx’s vision and mission.
2. Robust Compliance: Maintain a sustainable, robust, and compliant batch release and Marketing Authorization Holder (MAH), (MIA) system.
3. Foster Strong Partnerships: Excel at building and maintaining strong collaborative relationships with internal and external stakeholders to effectively deliver the product portfolio expansion commercial strategy.
4. Promote Cross-Functional Collaboration: Establish a seamless partnership with the Commercial counterparts in TechOps, ensuring strong alignment between Product Quality and cross-functional teams
ROLES AND RESPONSIBILITIES:
5. Lead, motivate and guide the Commercial and Batch Disposition teams to achieve excellence in all aspects of their work.
6. Drive and establish a clear quality and business objectives, ensuring timely monitoring of batch release performance and progress against defined goals.
7. Lead the PQ Commercial and batch disposition team in the global expansion efforts and the successful launch of new products, fostering innovation and operational readiness and also partner with the commercial manufacturing team in TechOps in the global expansion efforts and the successful launch of new products.
8. Drive the commercial and batch disposition team in maintaining the Marketing Authorization Holder (MAH) and (MIA )compliance and readiness for regulatory inspections.
9. Lead and drive initiatives to continuously improve the Quality Management System (QMS) and operational practices by benchmarking industry standards, evaluating stakeholder requirements, and defining performance metrics.
10. Lead the design and execution of a comprehensive, compliance framework for batch release processes, ensuring seamless adherence to regulatory standards across both commercial and clinical products.
11. Lead the design and execution of digital transformation of batch release processes to enhance efficiency, data integrity, and compliance.
12. Drive the creation and implementation of Standard Operating Procedures as an author, reviewer and approver.
SKILLS AND COMPETENCIES:
13. Collaborative leadership and team player
14. Ability to effectively lead, motivate and coach the team on quality and key business priorities
15. Excellent organizational and interpersonal skills
16. Excellent stakeholder management skills
17. Strong analytical and problem solving skills
18. Solid scientific writing and reporting skills
19. Extensive knowledge and experience in GMP area within a biopharmaceutical company
20. Extensive knowledge of Health authority regulations such as the FDA, EU and PMDA and ICH Guidelines and strong business knowledge of the major markets ( US, EU Japan etc)
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
21. Educated to degree level (preferably PHD or Masters) in a relevant commercial pharmacy or engineering discipline
22. 5- 10 years of experience in GMP and supply with in‐depth knowledge of commercial GMP and GDP processes.
23. Extensive experience in successfully managing Health Authority inspections
24. Certification as a Qualified Person is a desirable.