GRA Compliance Manager & Quality Champion in Marlow

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.,

• 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. 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. GRA Compliance & Quality Champion at Kyowa Kirin International plc, Marlow or Galashiels - United Kingdom.