At a Glance
- Tasks: Lead quality oversight of clinical trial materials and ensure compliance with EU regulations.
- Company: Kyowa Kirin International, a global leader in pharmaceuticals.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with opportunities to work with regulatory bodies.
- Why this job: Make a significant impact on patient safety and product quality in the pharmaceutical industry.
- Qualifications: Strong experience in EU GMP/GDP and leadership in Pharmaceutical Quality.
The predicted salary is between 80000 - 100000 £ per year.
Kyowa Kirin International plc in Marlow, UK or Hoofddorp, Netherlands seeks an Associate Director Global CMC QU – Clinical GMP/GDP to lead end‑to‑end quality oversight of IMPs and support QP certification and batch release. You will ensure compliance with EU GMP Annex 13 and GDP guidelines across CMOs, labs and 3PLs, driving data integrity and audits.
The role requires strong EU GMP/GDP experience, leadership in Pharmaceutical Quality, and collaboration with regulatory bodies for submissions.
Global CMC QA Director – Clinical GMP/GDP in Marlow employer: Kyowa Kirin
At Kyowa Kirin International, we are dedicated to making a meaningful impact in the pharmaceutical industry while fostering a culture of teamwork, innovation, and integrity. Our Marlow and Galashiels locations offer a collaborative environment where employees can thrive, with ample opportunities for professional growth and development. We prioritise employee well-being and inclusivity, ensuring that every team member feels valued and empowered to contribute to our mission of delivering life-changing solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Global CMC QA Director – Clinical GMP/GDP in Marlow
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Kyowa Kirin. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Kyowa Kirin.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Kyowa Kirin. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Kyowa Kirin is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Global CMC QA Director – 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!
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 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!
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, 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
✨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 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’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.
