About the job

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose.

Job Purpose:

Development and execution of the Global PV Audit Strategy and Global PV Audit Plan in close collaboration with the Director of Global Audit and R&D Quality. This includes defining risk standards and methodologies, audit methodology and best practices to ensure consistency of approach. Additional tasks are to support the continuous improvement of the Kyowa Kirin’s Quality System, the inspection management, the regulatory intelligence activities, the SOP and WI management, and the project liaison activities.

RESPONSIBILITIES

In close collaboration with the Director of Global Audit and R&D Quality

1. Audit process

• Provide input into and maintain the Strategy Document
• Perform annual risk assessment
• Develop, maintain and provide input to an adequate audit plan for global, regional and local trials, systems and compliance processes
• Manage qualified service providers for GQA, e.g., contract auditors
• Manage audits and contract auditors in line with the audit plan, Kyowa Kirin’s business model and applicable procedures
• Develop, and mentor junior PV audit team to:
• Plan, supervise, conduct, and support internal and external GVP audits
• Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
• Maintain a tracking tool for audits, findings and corrective and preventive actions
• Provide input for the development and maintenance of the audit tracking tool

1. Support the development, implementation, continuous improvement and documentation of Kyowa Kirin’s PV Quality System:

• Ensure that a comprehensive PV Quality System is developed, in place and adhered to.
• Ensure continuous improvement and enhancement of the PV Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
• Collaborate with the respective Functional Area Heads
• Collaborate with the respective Global and Regional Quality Leads and functions
• Foster a continuous improvement mentality within Kyowa Kirin
• Ensure the establishment and maintenance of the required Quality Documentation
• Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution
• Manage deviations reported by the Functional Areas and support them with resolution

1. Support inspections and health authority inspection management

• Support the preparation for GVP inspections
• Support the responses to Regulatory Authorities
• Support and provide input to the corrective and preventive actions
• Follow-up on the development, implementation, and completion of corrective and preventive actions with the inspected Functional Areas
• Maintain oversight and progress for inspections, findings and corrective and preventive actions

1. Support the management of the global, regional and local Standard Operating Procedures (SOPs) and Working Instructions (WIs)

• Ensure SOPs/ WIs are compliant with applicable requirements and regulations
• Ensure SOPs/ WIs mirror the actual Kyowa Kirin’s company processes

1. Support the validated state of computerised systems

• Provide business support as Global Quality for routine software/infrastructure lifecycle activities (systems introduction/maintenance/retirement)

1. Provide advice and act as project liaison

• Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and Kyowa Kirin’s employees
• Be accountable for quality-related input in decision making processes with relevance for GxP compliance
• Act as quality liaison for assigned projects

QUALIFICATIONS:

• Degree in natural science or equivalent number of years’ experience
• Qualified auditor; Minimum 5 years of Quality Management Auditing for Pharmacovigilance
• Minimum 10 years of clinical/industry/Regulatory Authority or otherwise relevant experience,
• Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, and Regulatory Affairs

Physical Requirements: (travel, lifting, typing, driving, sitting, special requirements around hours etc.)

• Located in Europe
• The employee will report to the Director of Global Audit and R&D Quality.

Key Competencies specific to the role: (what traits or capabilities must they have in order to succeed, examples include presentation skills, attention to detail, capability to influence and negotiate)

• Excellent leadership skills and knowledge of working in a cross-cultural business environment
• Excellent communication and presentation skills
• Understanding of change management processes
• Well versed with MS Office
• Very good communication skills (written and oral) in English
• Problem solving and resolution skills
• Analytical and creative thinking

BENEFITS:

In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development. Plus:

• Competitive salary
• Bonus
• Pension scheme
• Private medical insurance

To meet the expectations of our patients and to truly deliver on our Commitment to Life, we are continually looking for people who embrace this spirit. We are committed to providing a culture that offers both inspiration and reward – in terms of compensation and in work satisfaction. And in turn, we want people who’ll bring their unique ideas and diverse approaches, while also aligning to our ultimate goal of making people smile. If this sounds like a company that aligns with your values, we’d love for you to join us in our efforts.

Apply through below link

Associate Director, PV Auditor | Kyowa Kirin International plc. | LinkedIn