Bad Homburg, Germany
20 hours ago
Senior Director Supply Chain Quality (m/f/d)

We are the world's leading provider of products and services for kidney patients, offering innovative products and treatments of the highest quality. We are committed to continuously improving the quality of life of our 350,000 dialysis patients around the world every day. Our global network includes more than 39 production sites.

We are seeking a dynamic and strategic Senior Director of Supply Chain Quality (m/f/d) to lead and oversee our Global Quality Supply Chain organization, which spans four key regions: EMEA, LATAM, APAC, and NA. You will play a pivotal role in driving the execution of Supply Chain Quality processes across 20+ sites, ensuring adherence to our Quality Management System (QMS) and regulatory requirements, while promoting continuous improvement across the organization.

Your tasks:

Develop and execute a global Supply Chain Quality strategy aligned with the overarching global MSCQ strategy and business objectives, ensuring best practices across regionsLead the establishment, implementation, and continuous evolution of global Supply Chain Quality processes, focusing on key activities such as shipping, storage, handling, relabeling, and returnsPartner with global Supply Chain teams to standardize practices and ensure compliance with Good Distribution Practices (GDP) and regulatory requirements.Manage regulatory inspections and ensure all Supply Chain locations comply with global and local regulations, including FDA, MDD/MDR, and GMPImplement a robust monitoring system (including leveragering AI in data analytics) for Supply Chain Quality performance, reporting on KPIs and addressing high-risk logistics issues, audits, non-conformances, CAPA, and complaintsOversee the timely execution of field actions and coordinate the handling of product incidents, ensuring efficient routing and compliance with QMSDrive risk-based self-inspection planning and ensure corrective actions are taken to maintain quality and complianceApprove suppliers, subcontractors, and outsourced activities to ensure adherence to GDP and other relevant regulatory requirements

Your profile:

Master’s degree in Science, Engineering, or an MBAMinimum of 10 years in Quality Assurance, Quality Engineering, or Supply Chain Quality, preferably within the Medical Device/Pharmaceutical industriesAt least 5-7 years of leadership experience in managing diverse, international teams across multiple facilitiesExtensive experience with medical device and pharmaceutical regulations (e.g., FDA, MDD/MDR, EU GMP, AMG, ICH Q10), and familiarity with Good Distribution Practice (GDP)Experience with electronic quality management systems (eQMS) and validation methods is a plusProven track record in implementing global processes and standards in a complex, multi-regional environmentExceptional communication and stakeholder management skills, with the ability to engage and influence across all levels of the organizationAbility to analyze complex challenges, develop actionable solutions, and lead strategic initiatives to drive continuous improvementHands-on experience leading regulatory authority audits and ensuring compliance with international quality standardsYou build strong relationships and networks both inside and outside the organization to achieve collective successVery good knowledge of written and spoken English, knowledge of German is a plus

Our offer to you:

There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

The opportunity to work on a mobile basis (hybrid)Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the worldIndividual opportunities for self-determined career planning and professional developmentA corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution togetherA large number of committed people with a wide range of skills, talents and experienceThe benefits of a successful global corporation with the collegial culture of a medium-sized company

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