WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

Participate in the compliance with GDP/GDP-API & GMP requirements for the distribution of Medicinal Product (e.g., Drug Substance/Drug Product/Finished Product/QP Certified Finished Product) into the EMEA-ROW region, including import and export activities.

Key Responsibilities:

• Ensure all aspect of Kyowa Kirin’s Quality Management Systems (QMSs) are applied to medicinal product distribution activities:
• Actively contributes to activities under the responsibility of the GDP Responsible Person, the Designated Person for API and the QP for distribution of Drug Substance(s)/Drug Product(s)/Finished Product(s)/QP Certified Finished Product(s).
• Execute supplier and customer verification management (e.g., onboarding/offboarding, contractor risk assessment, Bona Fide and Quality Technical agreement(s)).
• Executes Quality Assurance of Stock management (e.g., QA oversight of Inbound/Outbound, non-conformities, returns, stock reconciliation and destruction) with no delay to QA in close contact/cooperation with internal (e.g. SC/ finance) & external stakeholders (3PL(s)/customer(s))
• Drives the monitoring of the distribution contractors’ quality performance according to a set of defined metrics with periodic reporting and proposes actions/improvement where applicable.
• Drives continuous improvement activities of the established QMS to support continuous compliance with the established licences.
• Leads investigations of distribution/supply non-conformities, deviations and temperature excursions and ensure appropriate CAPA are identified and implemented.
• Closely liaise with local/international Kyowa Kirin stakeholders (e.g. KKS/EMEA/Japan) and external stakeholders.
• Drives continuous improvement in relation to DP/GDP-API & GMP requirements for the distribution of Medicinal Product
• Prepare and maintain related Technical (Quality) Agreements that roles and responsibilities between the contracted parties are clearly defined and implemented.

Position Requirements

• Degree in life science or equivalent with preference of a minimum of 3 to 5 years’ experience in GDP.
• Experience of working within the pharmaceutical industry operating in a Quality Assurance position at a manufacturing/distribution site.
• Excellent working knowledge of GDPs for the distribution of commercial medicinal products
• Fluent in English language and good level of Dutch - both verbal and written.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.