GRA Compliance Manager & Quality Champion

Overview

GRA Compliance & Quality Champion

at Kyowa Kirin International plc

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 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.

Responsibilities

Key Responsibilities:

• 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

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.

No agencies please.