メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証

・Ensure compliance with internal standards, local, and international quality and regulatory guidelines for clinical trials supply chain activities
・Deliver monthly reporting on key performance indicators and provide insights on trends, risks, and mitigation plans
・Provide guidance and advice on regulatory and quality matters to clients, suppliers, and internal associates
・Handle internal and external audits and follow-up on resulting observations and opportunities for improvement
・Mentor and develop the Quality team to deliver outstanding results
・Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business
・Lead management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvement
・Establish effective communication processes to ensure timely reporting of quality issues to the appropriate levels of management
・Take a leadership role in service and quality improvement initiatives

■休日：土, 日, 祝日, 夏季休暇, 年末年始

・Bachelor’s degree or equivalent experience in life science/medical/pharmacy/quality assurance/regulatory affairs or related field
・5+ years of strong QA and production experience or experience in GMP/QMS/ISO9001 settings in quality assurance
・Knowledge of IMP process, including handling complex protocols and key clients
・Ability to handle complex problems/projects with independent decision-making and analytical thinking skills
・Flexible, adaptable, and strong customer management skills
・Ability to work independently under pressure and handle multiple tasks
・Strong leadership and influencing skills
・Good organizational, written, and verbal communication skills in English and Japanese

■職種未経験者：不可