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- Tasks: Manage Quality Assurance systems and conduct audits to ensure compliance.
- Company: Join Kyowa Kirin International, where we make people smile through innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Be a key player in ensuring the quality of life-changing solutions.
- Qualifications: Bachelor’s degree in science/life sciences and 3+ years in GCP/GLP QA.
- Other info: Dynamic team environment with a commitment to integrity and teamwork.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Manager, R&D QA, Global Audit, Inspections and R&D Quality role at Kyowa Kirin International plc.
Overview
At Kyowa Kirin International (KKI), our purpose is to make people smile. We embed care into everything we do and deliver life‑changing solutions sooner. Our culture is rooted in Teamwork, Commitment to Life, Innovation, and Integrity.
Job Purpose
The Manager, R&D QA, Global Audit, Inspections and R&D Quality is responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The R&D QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and provide key quality input to KK’s R&D function.
Responsibilities
- Acts as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks.
- Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and quality agreement preparation.
- Develops and delivers GCP-related training to KK staff as needed.
- Performs, reports assigned GCP/GLP audits of KK studies, including but not limited to, clinical investigator sites, vendor/CROs, internal system/processes, clinical data and documents, as applicable.
- Prepares timely well‑written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA as per KK standards.
Qualifications
- Bachelor’s degree required and in science/life sciences preferred.
- Strong experience in drug development and 3+ years of experience in GCP/GLP Quality Assurance including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements.
Kyowa Kirin International is an equal opportunities employer.
Manager, R&D QA, Global Audit, Inspections and R&D Quality in Marlow employer: Kyowa Kirin International plc.
Contact Detail:
Kyowa Kirin International plc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, R&D QA, Global Audit, Inspections and R&D Quality in Marlow
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. We want you to show them that you’re not just a fit for the role, but also for the team and the mission of making people smile!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We believe that being well-prepared can make all the difference when it comes to impressing your interviewers.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in keeping you top of mind. We recommend expressing your appreciation for the opportunity and reiterating your enthusiasm for the role.
We think you need these skills to ace Manager, R&D QA, Global Audit, Inspections and R&D Quality in Marlow
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Manager, R&D QA role. Highlight your experience in GCP/GLP Quality Assurance and any relevant audits you've conducted. We want to see how you can bring value to our team!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in R&D and how your background aligns with our mission at Kyowa Kirin. Keep it engaging and personal – we love to see your personality!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've improved processes or contributed to successful audits. This helps us understand the impact you've made in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at Kyowa Kirin!
How to prepare for a job interview at Kyowa Kirin International plc.
✨Know Your Regulations
Make sure you brush up on your knowledge of EMA, FDA, MHRA, and ICH regulations. Being able to discuss these in detail will show that you’re not just familiar with the standards but can also apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed GCP/GLP quality assurance processes. Highlight any audits you've conducted or training sessions you've led, as this will demonstrate your hands-on experience and leadership skills.
✨Understand the Company Culture
Familiarise yourself with Kyowa Kirin's values of Teamwork, Commitment to Life, Innovation, and Integrity. Be ready to discuss how your personal values align with theirs and how you can contribute to their mission of making people smile.
✨Prepare Questions
Have a list of thoughtful questions ready to ask at the end of your interview. This could include inquiries about their QA processes or how they handle quality-related risks. It shows your genuine interest in the role and helps you assess if it’s the right fit for you.
