At a Glance
- Tasks: Drive global regulatory compliance and champion quality improvements in a dynamic pharmaceutical environment.
- Company: Kyowa Kirin International, a caring and innovative pharmaceutical company.
- Benefits: Inclusive culture, career growth opportunities, and the chance to make a real difference.
- Other info: Flexible working hours and travel opportunities for global collaboration.
- Why this job: Join us to push boundaries in medicine and help improve lives every day.
- Qualifications: Degree in Life Sciences and experience in pharmaceutical Regulatory Affairs required.
The predicted salary is between 50000 - 60000 £ per year.
- Overview
- GRA Compliance & Quality Champion
- Marlow or Galashiels – United Kingdom
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
Supporting global regulatory compliance by driving Gx P 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.
Responsibilities
- Support the implementation and maintenance of global regulatory compliance frameworks, ensuring adherence to corporate policies, procedures, and applicable regulations.
- Proactively monitor Gx P 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
Qualifications
- 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.
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GRA Compliance & Quality Champion in Galashiels 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.
