Associate Director Global CMC QU – Clinical GMP/GDP

Overview

Associate Director Global CMC QU – Clinical GMP/GDP

at Kyowa Kirin International plc

Marlow, UK or Hoofddorp, Netherlands

 

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

You will be responsible for providing end-to-end quality oversight of clinical investigational medicinal products (IMPs) in accordance with EU GMP (EudraLex Volume 4), including Annex 13, and EU GDP Guidelines (2013/C 343/01)

The role provides independent QA oversight and regulatory support to EU Qualified Persons (QPs), ensuring that certification and release of investigational medicinal products is performed in compliance with EU legal and regulatory requirements. The position maintains quality oversight of CDMOs, packaging sites, laboratories, and Third-Party Logistics providers (3PLs) involved in the manufacture, storage, and distribution of clinical trial material (CTM)

Responsibilities

Key Responsibilities:

• Provide QA oversight of clinical IMP manufacturing, packaging, testing, release, and distribution activities
• Support EU Qualified Person (QP) certification and batch release processes
• Ensure compliance with EU GMP Annex 13 requirements, including labeling, traceability, accountability, and retention samples
• Review and approve GMP documentation, including batch records, CoAs, deviations, investigations, and quality events
• Lead QA support for clinical technology transfers, process start-ups, and product lifecycle activities
• Provide quality oversight of clinical supply chain operations, including transportation, temperature-controlled logistics, and distribution
• Ensure clinical trial materials remain fully traceable throughout the supply chain.
• Manage Quality Technical Agreements (QTAs) with CDMOs, laboratories, distribution partners, and 3PL providers
• Plan, conduct, and support risk-based GMP and GDP audits of external partners.
• Support regulatory submissions, inspections, and health authority interactions
• Author, review, and maintain Clinical GMP/GDP procedures and quality system documentation
• Ensure compliance with data integrity requirements, including EU GMP Annex 11 and ALCOA+ principles

Qualifications

Position Requirements:

• Bachelor’s degree in a relevant scientific/technical discipline or equivalent experience in the pharmaceutical industry
• Solid leadership experience within Pharmaceutical Quality in the pharmaceutical Industry, with significant exposure to EU Clinical GMP and GDP
• Prior experience working with a Qualified Person (QP) responsible for investigational medicinal products, as well as experience in batch disposition (release), is preferred for success in this position
• Strong knowledge of EU GMP (EudraLex Volume 4, Annex 13) and EU GDP Guidelines
• Experience with biologics and/or small molecule clinical products.
• Demonstrated ability to assess quality and regulatory risk and provide sound compliance judgments
• Experience in QA, QC, auditing, or regulatory affairs within a clinical development environment 

  

Kyowa Kirin International is an equal opportunities employer.

 

No agencies please.