At a Glance
- Tasks: Drive global regulatory compliance and champion quality across teams.
- Company: Kyowa Kirin International, a leader in pharmaceutical innovation.
- Benefits: Competitive salary, travel opportunities, and a dynamic work environment.
- Other info: Join a culture of continuous improvement and professional growth.
- Why this job: Make a real impact on global compliance and quality standards.
- Qualifications: Degree in Life Sciences and experience in Regulatory Affairs required.
The predicted salary is between 40500 - 49500 £ per year.
Overview
GRA Compliance & Quality Champion at Kyowa Kirin International plc, Marlow or Galashiels – United Kingdom.
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
- 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. No agencies please.
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GRA Compliance Manager & Quality Champion in Marlow employer: Kyowa Kirin International plc.
Kyowa Kirin International plc is an exceptional employer located in the picturesque towns of Marlow and Galashiels, offering a dynamic work culture that prioritises collaboration and continuous improvement. Employees benefit from robust professional development opportunities, a commitment to quality and compliance, and the chance to make a meaningful impact in global regulatory affairs. With a focus on employee well-being and a supportive environment, Kyowa Kirin fosters a culture where innovation thrives and every team member can contribute to the company's success.
Contact Details:
Kyowa Kirin International plc. Recruitment Team
