Head of QA,CMC/ Hinsekiの転職・求人情報 27982075

募集要項

募集背景: New role and first hire in QA, CMC departments with the establishment of Japan office

仕事内容: Job Description Summary:
We are seeking an experienced and highly skilled Head of CMC （Chemistry, Manufacturing, and Controls） with a strong background in Quality Assurance （QA） to join our team in Japan. This pivotal role involves leading our CMC activities and ensuring the highest standards of quality and compliance throughout the product lifecycle. The ideal candidate will possess extensive knowledge of CMC processes, regulatory requirements, and quality assurance principles, along with excellent leadership and communication skills.

応募資格

必須: • Advanced degree in chemistry, biochemistry, pharmacy, or a related field （PhD, MSc preferred）.
• Minimum of 5 years of experience in QA roles within the pharmaceutical or biotechnology industry.
• Experience working with regulatory bodies or supporting regulatory submissions （PMDA, MHLW, etc.）
• GMP/GQP/QMS regulations, guidelines and compliance requirements.
• Strong organizational skills to manage multiple tasks and projects efficiently.
• Ability to work independently and collaboratively within a team environment while liaising with multiple departments and demonstrating exceptional self－management skills.
• Fluent in Japanese and English, both written and spoken.

事業内容・会社の特長: An U.S. bio venture company that has shown substantial growth in global with various product pipelines including their groundbreaking gene therapy drug approved in the U.S. that is the first and only treatment that addresses the genetic cause of a type of rare disease.