Global Clinical QA Lead
1 day ago
Santen is a global company dedicated to eye health, striving to contribute to the realization of "Happiness with Vision" by providing valuable products and services to patients, consumers, and medical professionals worldwide. As a specialized company, Santen has been committed to helping people maintain and improve their eye health since its establishment in Japan in 1890. Guided by its CORE PRINCIPLE, "Tenki ni sanyo suru," Santen engages in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people worldwide.
In this role, you will provide direct support to the Head of Global Clinical Quality (CQA) and Pharmacovigilance Quality Assurance in managing compliance related to cGCP, pharmacovigilance, and other related activities. You will oversee the GCP audit programs, develop, maintain, and continuously improve the GCP Quality System. Participate in internal audits and global regulatory inspections, including FDA/EMA. As a subject matter expert for specific Good Clinical Practices. Through the execution of these operations, you will ensure compliance with GCP and other relevant regulations, contributing to the realization of "Happiness with Vision" for people around the world.
The ideal candidate will have 6+ years of experience in Clinical Quality Assurance, Quality Assurance, or Clinical Operations within Pharma or Biotechnology industry. Experience with all phases of clinical trials. Broad knowledge of risk-based quality systems consistent with Good Clinical Practice. Ability to identify and resolve quality issues. Attention to detail as well as crisp, clear and concise style in written and oral communications. Demonstrated ability to work independently and flexibly in a fast-paced, high-growth environment. A Bachelor's degree in a scientific field is required. Fluency in English language skills is essential. Experience supporting inspection-readiness activities (FDA, HC & EMA) is a plus.
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Global Clinical QA Lead
1 day ago
Helsinki, Uusimaa, Finland Santen Pharmaceutical Co. Full timeJob DescriptionWe are seeking a highly skilled and experienced Global Clinical QA Manager to join our team at Santen Pharmaceutical Co. This is an exciting opportunity to play a key role in ensuring the highest standards of quality in our clinical operations.Responsibilities:Support the Head of Global Clinical Quality in managing compliance related to cGCP,...
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Senior Clinical Operations Specialist
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Helsinki, Uusimaa, Finland Santen Pharmaceutical Co. Full timeOur Ideal CandidateWe are looking for a highly motivated and experienced Global Clinical QA Manager who can contribute to our success.The successful candidate will have a strong understanding of Good Clinical Practice (GCP) and quality management principles, and be able to provide guidance and support to our clinical development teams.Main...
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Senior QA Specialist
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Helsinki, Uusimaa, Finland Santen Full timeWhat We're Looking ForSanten is seeking a highly skilled Clinical Quality Assurance professional to join our team. The ideal candidate will have 6+ years of experience in Clinical Quality Assurance, Quality Assurance, or Clinical Operations within Pharma or Biotechnology industry. Experience with all phases of clinical trials. Broad knowledge of risk-based...
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