QM Manager GDP and Deputy Responsible Person Wholesale

Kedrion Biopharma GmbH, a subsidiary of Kedrion S.p.A., is a pharmaceutical wholesaler that distributes finished medicinal products derived from human plasma for the treatment of numerous—in some cases rare and severe—diseases, such as coagulation disorders, neurological disorders, and immunodeficiencies, across Germany, Austria, Poland, and Portugal. The storage and distribution of these medicinal products are handled by a contracted logistics service provider.

Headquartered in Italy, Kedrion S.p.A. is a steadily growing company that has expanded its global influence within the plasma-processing industry. Kedrion S.p.A. is now one of the top five global providers of plasma derivatives.

To strengthen our Quality Management (QM) team at our corporate headquarters in Gräfelfing (near Munich), we are seeking to recruit—as soon as possible—a

Deputy Responsible Person for Wholesale (pursuant to § 52a AMG) / GDP Quality Manager (m/f/d)

In your role as Deputy Responsible Person / GDP Quality Manager, you will serve as the primary quality contact for the logistics and sales departments. You will support the Responsible Person for Wholesale (pursuant to § 52a AMG) in managing quality-related activities regarding the storage, transport, and distribution of medicinal products (pharmaceutical wholesale) and contribute to the implementation of and compliance with GDP and internal quality standards.

Duties and responsibilities

• Supporting the Responsible Person in maintaining the quality system for wholesale and distribution activities
• Ensuring implementation of and compliance with the requirements of the German Medicinal Products Distribution Ordinance (AM-HandelsV) and EU GDP guidelines within the distribution function and at our 3PL service providers
• Approving and monitoring all outsourced activities that impact Good Distribution Practice (GDP)
• Qualifying customers and suppliers
• Conducting QA assessments regarding logistics and quality deviations
• Deciding on the marketability of newly delivered, returned, rejected, or recalled medicinal products, or products suspected of being falsified
• Handling customer complaints and product-related claims
• Coordinating and executing medicinal product recalls
• Managing training, changing control, risk, deviations, and CAPA (Corrective and Preventive Actions)
• Document management
• Conducting internal and external audits
• Creating and managing quality-related documents and contracts
• Communicating internally with colleagues in Sales, Pharmacovigilance, and Medical Affairs, and externally with staff at contracted service providers regarding GMP/GDP-related questions and issues

Your profile

• University degree (Bachelor’s/Master’s/University of Applied Sciences) in Natural Sciences or Pharmacy, or an equivalent qualification
• Sound knowledge of relevant laws, regulations, and guidelines (e.g., AMG, AM-HandelsV)
• Experience and knowledge in the fields of GDP and GMP
• Experience and knowledge in quality assurance and quality management
• Experience with logistics processes (desirable)
• Strong communication skills, reliability, and ability to work in a team
• Solution-oriented and structured approach to work
• High level of flexibility and self-motivation
• Hands-on mentality
• Mindset and strategic thinking
• Reliability and a strong commitment to quality
• Fluency in German and English (spoken and written)
• Proficiency in using modern IT infrastructure and standard software applications (MS Office suite)

What we offer

• A varied role with significant responsibility and scope for independent initiative
• A competent, dedicated team characterized by mutual respect ready to support and welcome you
• Individualized onboarding
• Work in an exciting environment focused on implementing GDP guidelines for the distribution of vital blood plasma products—essential for significantly supporting the quality of life and survival of many patients
• Attractive compensation
• Regular internal and external training opportunities

Kedrion Biopharma GmbH - Bahnhofstraße 96 – 82166 Gräfelfing (near Munich)