Auditor (Contract) Position
4 weeks ago
We are seeking a highly skilled Auditor to join our team at Kyowa Kirin International. As a key member of our Quality Assurance department, you will be responsible for ensuring the implementation, execution, and maintenance of our EMEA GxP Quality Management Systems.
Key Responsibilities:- Develop and maintain an adequate audit plan for global, regional, and local trials, systems, and compliance processes.
- Manage qualified service providers for GQA, including contract auditors.
- Perform annual risk assessments and ensure continuous improvement of the PV Quality System.
- Collaborate with Functional Area Heads, Global and Regional Quality Leads, and other functions to foster a continuous improvement mentality within Kyowa Kirin.
- Ensure the establishment and maintenance of required Quality Documentation.
- Identify process gaps and deficiencies in the Quality System and collaborate with other Functional Areas and partners for resolution.
- Degree in natural science or equivalent number of years' experience.
- Qualified auditor with experience in Quality Management Auditing for Pharmacovigilance.
- Clinical/industry/Regulatory Authority or otherwise relevant experience.
- Expert knowledge/experience in relevant regulations and guidance documents, such as Pharmacovigilance, Clinical Development, Medical Device, IMP management, and Regulatory Affairs.
We offer a dynamic and challenging work environment with opportunities for professional growth and development. If you are a motivated and experienced Auditor looking for a new challenge, please submit your application.
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Global Pharmacovigilance Quality Lead
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Marlow, United Kingdom Kyowa Kirin Full timeJob SummaryAs a key member of the Kyowa Kirin International team, the Global Pharmacovigilance Quality Lead will be responsible for leading the development and execution of the Global Pharmacovigilance Audit Strategy and Schedule. This includes maintaining risk standards and methodologies, as well as ensuring consistency of approach across the...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director of Global Pharmacovigilance Quality AssuranceAt Kyowa Kirin International, we are committed to making a difference in the lives of our patients and their families. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key...
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Director GVP Quality Lead
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Marlow, United Kingdom Kyowa Kirin Full timeAbout the RoleKyowa Kirin International is seeking a highly skilled and experienced professional to fill the position of Director GVP Quality. As a key member of our team, you will be responsible for leading the development and execution of the Global Pharmacovigilance (GVP) Audit Strategy and Global Pharmacovigilance Audit Schedule.Key ResponsibilitiesPlan,...
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Director GVP Quality Lead
2 weeks ago
Marlow, United Kingdom Kyowa Kirin Full timeJob SummaryWe are seeking a highly skilled and experienced Director GVP Quality to join our team at Kyowa Kirin International. As a key member of our Quality Assurance department, you will be responsible for developing and executing the Global Pharmacovigilance Audit Strategy and Global Pharmacovigilance Audit Schedule.Key ResponsibilitiesPlan, conduct, and...
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Director GVP Quality Lead
2 weeks ago
Marlow, United Kingdom Kyowa Kirin Full timeJob SummaryWe are seeking a highly skilled Director GVP Quality to join our team at Kyowa Kirin International. The successful candidate will be responsible for leading the development and execution of the Global Pharmacovigilance Audit Strategy and Schedule.Key ResponsibilitiesPlan, conduct, and support internal and external GVP auditsFollow-up on the...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of those who need it most. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key Responsibilities:Develop and execute the Global...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of our patients and their families. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key Responsibilities:Develop and execute the...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of our patients and their families. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key Responsibilities:Develop and execute the...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of those who need it most. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key Responsibilities:Develop and execute the Global...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of those who need it most. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key Responsibilities:Develop and execute the Global...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of our patients and their families. As a key member of our team, you will play a vital role in ensuring the highest standards of quality and compliance in our Global Pharmacovigilance (GVP) operations.Key Responsibilities:Develop and execute the...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of our patients and their families. As a key member of our team, you will play a vital role in ensuring the highest standards of quality and compliance in our Global Pharmacovigilance (GVP) operations.Key Responsibilities:Develop and execute the...
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Marlow, United Kingdom Kyowa Kirin Full timeJob Title: Director GVP QualityAt Kyowa Kirin International, we are committed to making a difference in the lives of those who need it most. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.Key Responsibilities:Develop and execute the Global...
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