At a Glance
- Tasks: Support global regulatory compliance and drive quality standards in a dynamic pharmaceutical environment.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Inclusive culture, career growth opportunities, and a chance to make a real impact.
- Other info: Flexible working hours and opportunities for international travel.
- Why this job: Join us to champion quality and compliance while making a difference in patients' lives.
- Qualifications: Degree in Life Sciences and experience in pharmaceutical Regulatory Affairs required.
The predicted salary is between 50000 - 60000 £ per year.
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: Supporting global regulatory compliance by driving GxP standards, managing risk, and ensuring audit readiness. Collaborate cross‑functionally to embed quality, deliver robust compliance frameworks, and champion continuous improvement across global regulatory teams.
Key Responsibilities:
- Support the implementation and maintenance of global regulatory compliance frameworks, ensuring adherence to corporate policies, procedures, and applicable regulations.
- Proactively monitor GxP compliance across GRA, identifying gaps and driving timely corrective and preventive actions.
- Own and maintain risk registers and compliance dashboards, providing clear visibility to leadership and ensuring effective mitigation of identified risks.
- Oversee the management and timely closure of deviations, change controls, and corrective actions within GRA.
- Define, monitor, and continuously improve GRA metrics and KPIs, ensuring appropriate mitigation actions are implemented and tracked.
- Ensure effective rollout and adoption of new or updated procedures across global and regional teams.
- Champion a culture of quality and compliance, promoting best practices and continuous improvement across GRA.
- Lead global audit and inspection readiness activities, including preparation, training, and ensuring documentation meets regulatory standards.
- Collaborate cross‑functionally (e.g., Quality Assurance, and other teams) to embed quality principles within operational activities.
Position Requirements:
- Degree in Life Sciences (or equivalent) with experience in pharmaceutical Regulatory Affairs.
- Willingness to travel (UK and internationally) with occasional overnight stays.
- Flexible approach to working hours to support global collaboration.
- Strong leadership and interpersonal skills, with the ability to influence and collaborate effectively.
- Excellent communication and negotiation capabilities (written and verbal).
- Highly analytical, with strong problem‑solving abilities and attention to detail.
- Well‑organised, able to manage multiple priorities in a fast‑paced environment.
- Confident in interpreting and presenting complex scientific information.
- A results‑driven mindset, demonstrating urgency and excellence in execution.
Kyowa Kirin International is an equal opportunity employer.
GRA Compliance & Quality Champion in Galashiels employer: Kyowa Kirin International
At Kyowa Kirin International, we pride ourselves on being an inclusive and innovative pharmaceutical company that prioritises the well-being of our employees and the communities we serve. Located in the picturesque towns of Marlow and Galashiels, we offer a collaborative work culture that fosters teamwork and commitment to life-changing solutions, alongside opportunities for professional growth and development. Join us to be part of a mission-driven team where your contributions truly make a difference and where we celebrate every success together.
StudySmarter Expert Advice🤫
We think this is how you could land GRA Compliance & Quality Champion in Galashiels
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We think you need these skills to ace GRA Compliance & Quality Champion in Galashiels
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.
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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.
