At a Glance
- Tasks: Oversee quality of clinical products and ensure compliance with EU regulations.
- Company: Join Kyowa Kirin, a caring and innovative pharmaceutical company.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with strong leadership and career advancement opportunities.
- Why this job: Make a real difference in patients' lives while pushing the boundaries of medicine.
- Qualifications: Bachelor's degree in a relevant field and experience in pharmaceutical quality.
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.
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).
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.
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.
UK salary - £80,000-121,000
Netherlands salary - €93,000-140,000
Associate Director Global CMC QU – Clinical GMP/GDP in Marlow employer: Kyowa Kirin International
Kyowa Kirin International is an exceptional employer, dedicated to embedding care into every aspect of our work, making a meaningful difference for patients and their families. Our inclusive culture, rooted in values such as Teamwork, Commitment to Life, Innovation, and Integrity, fosters an environment where employees are encouraged to take bold actions and drive life-changing solutions. With ample opportunities for professional growth and a commitment to continuous improvement, working at our Orchard location offers a unique chance to be part of a team that truly impacts lives.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Global CMC QU – Clinical GMP/GDP in Marlow
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We think you need these skills to ace Associate Director Global CMC QU – Clinical GMP/GDP in Marlow
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Kyowa Kirin International!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Kyowa Kirin International that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Kyowa Kirin International!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Kyowa Kirin International, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Kyowa Kirin International
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Kyowa Kirin International that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Kyowa Kirin International’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
