At a Glance
- Tasks: Ensure quality and compliance of life-changing medicines in a fast-paced environment.
- Company: Kyowa Kirin International, a mission-driven pharmaceutical company focused on patient care.
- Benefits: Opportunity to make a meaningful impact and work with a supportive team.
- Other info: Flexible working hours and international travel opportunities.
- Why this job: Join us to contribute to global product quality and deliver life-changing solutions.
- Qualifications: Degree in Life Sciences and experience in pharmaceutical manufacturing required.
The predicted salary is between 50000 - 60000 £ per year.
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: Kyowa Kirin is seeking a proactive and detail‑driven Senior Quality Assurance Specialist to support our global product supply operations. This is an excellent opportunity to play a key role in ensuring the quality, safety and compliance of our commercial and clinical products within a collaborative, fast‑moving environment.
Responsibilities:
- Lead QA oversight for complex product supply activities with minimal supervision.
- Apply strong working knowledge of GxP, KKS QMS, and global regulatory expectations (MHRA, FDA, EU, ICH).
- Communicate quality issues promptly and professionally across the business to drive compliant, timely resolutions.
- Influence project teams to ensure GMP compliance and identify quality gaps early.
- Prepare, negotiate and maintain Quality/Technical Agreements with third‑party manufacturers and suppliers.
- Review GxP documentation and CMO records to support compliant product release.
- Monitor and verify effective implementation of CAPAs.
- Deliver GxP training and refresher sessions to internal teams.
- Provide KPI reporting to QA management to support continuous improvement.
- Participate in product recall assessments to protect patient safety.
Qualifications:
- A degree in Life Sciences or equivalent.
- Strong experience in pharmaceutical manufacturing, supply or distribution.
- Excellent understanding of international GxPs and regulatory requirements.
- Previous QA experience in aseptic manufacturing (biologics/monoclonal antibodies advantageous).
- Knowledge of QC and stability testing for solids, semi‑solids and parenteral.
- Familiarity with validation requirements, ICH guidelines and Quality Management Systems (e.g., ICH Q10).
- Strong communication, analytical and problem‑solving skills.
- Ability to work independently, manage priorities and operate effectively in a virtual, global environment.
- High attention to detail and commitment to flawless execution.
Additional Requirements:
- Ability to travel internationally as needed.
- Comfortable with extended periods of desk‑based work.
- Flexibility for occasional early/late working.
Why Join Us? This 15 months fixed‑term role offers the chance to make a meaningful impact on global product quality while working with a supportive, mission‑driven team. If you’re results‑oriented, thrive in a fast‑paced environment and want to contribute to delivering life‑changing medicines, we’d love to hear from you. Kyowa Kirin International is an equal opportunity employer. No agencies please.
Senior QA Product Specialist – 15 Months FTC in Marlow employer: Kyowa Kirin
At Kyowa Kirin International, we are dedicated to making a difference in the lives of patients and their families through our commitment to quality and innovation. Our inclusive work culture fosters teamwork and integrity, providing employees with opportunities for professional growth and development in a fast-paced environment. Join us in our mission to deliver life-changing solutions while enjoying a supportive atmosphere that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Senior QA Product Specialist – 15 Months FTC in Marlow
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Kyowa Kirin.
We think you need these skills to ace Senior QA Product Specialist – 15 Months FTC in Marlow
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Kyowa Kirin.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Kyowa Kirin. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Kyowa Kirin
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Kyowa Kirin.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Kyowa Kirin achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
