Kyowa Kirin International
GRA Compliance & Quality Champion
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GRA Compliance & Quality Champion
GRA Compliance & Quality Champion
Location: Marlow or Galashiels – United Kingdom
Our Purpose: Driving Medicine Forward
WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE.
At Kyowa Kirin International (KKI), we go beyond drug discovery and development—we embed care into everything we do to make a meaningful impact daily.
We are an inclusive pharmaceutical company that prioritises what matters most to patients, families, and healthcare professionals, empowering our teams to take bold actions and deliver life-changing solutions—sooner.
Rooted in our core values—Teamwork, Commitment to Life, Innovation, and Integrity—we push boundaries to create extraordinary impact and foster an exceptional work environment.
Job Purpose
This role focuses on global regulatory compliance, driving GxP standards, managing regulatory risk, and ensuring audit readiness. You will collaborate across functions to embed quality, deliver robust compliance frameworks, and champion continuous improvement for global regulatory teams.
Responsibilities
Key responsibilities include:
- Supporting the implementation and maintenance of global regulatory compliance frameworks, ensuring alignment with corporate policies, procedures, and applicable regulations.
- Proactively monitoring GxP compliance across Global Regulatory Affairs (GRA), identifying gaps, and driving corrective and preventive actions (CAPAs) promptly.
- Owning and updating risk registers and compliance dashboards, providing strategic visibility to leadership while ensuring risk mitigation strategies are effective.
- Managing and closing deviations, change controls, and corrective actions within GRA, maintaining timely and accurate records.
- Defining, monitoring, and improving GRA metrics and KPIs, ensuring mitigation actions are implemented and tracked.
- Facilitating the effective rollout of new or updated procedures across global and regional teams.
- Championing a culture of quality and compliance, promoting best practices and continuous improvement within GRA.
- Leading global audit and inspection readiness, including preparation, team training, and documentation compliance with regulatory standards.
- Collaborating cross-functionally (e.g., with Quality Assurance teams and other departments) to integrate quality into all operational activities.
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Requirements
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Degree: Life Sciences (or equivalent) with experience in pharmaceutical Regulatory Affairs.
Skills & Competencies:
- Ability and willingness to travel (UK and internationally), including occasional overnight stays.
- Flexibility in working hours to support global collaboration.
- Strong leadership, interpersonal skills, and influence to collaborate effectively with multidisciplinary teams.
- Outstanding written and verbal communication, along with negotiation abilities.
- Highly analytical, with strong problem-solving skills and meticulous attention to detail.
- Exceptionally organised, capable of managing multiple priorities in a dynamic environment.
- Confidence in explaining and presenting complex scientific information clearly.
- Results-driven mindset, with urgency and excellence in execution.
About Kyowa Kirin International
Kyowa Kirin International is committed to being an equal opportunity employer. No agencies, please.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
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