Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Warehouse, Will work with hazardous/toxic materials

Job Description

Thermo Fisher Scientific Inc. is looking for a motivated and experienced professional to join our team in Japan as a Quality Manager. In this role, you will be responsible for ensuring that clinical supplies are stored and distributed in compliance with Fisher Clinical Services approved procedures and policies, as well as industry regulations such as cGMP, cGDP. This position offers a chance to contribute to high-quality systems and work closely with both internal and external partners on quality-related issues.

Job Responsibilities:

Ensure compliance with internal standards, local, and international quality and regulatory guidelines for clinical trials supply chain activitiesDeliver monthly reporting on key performance indicators and provide insights on trends, risks, and mitigation plansProvide guidance and advice on regulatory and quality matters to clients, suppliers, and internal associatesHandle internal and external audits and follow-up on resulting observations and opportunities for improvementMentor and develop the Quality team to deliver outstanding resultsPartner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the businessLead management reviews of process performance, product quality, and the Pharmaceutical Quality System, advocating for continual improvementEstablish 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

Job Requirements:

Bachelor’s degree or equivalent experience in life science/medical/pharmacy/quality assurance/regulatory affairs or related field5+ years of strong QA and production experience or experience in GMP/QMS/ISO9001 settings in quality assuranceKnowledge of IMP process, including handling complex protocols and key clientsAbility to handle complex problems/projects with independent decision-making and analytical thinking skillsFlexible, adaptable, and strong customer management skillsAbility to work independently under pressure and handle multiple tasksStrong leadership and influencing skillsGood organizational, written, and verbal communication skills in English and Japanese

Thermo Fisher Scientific Inc. is an equal opportunity employer (EOE) and values diversity in our workforce. We are committed to providing equal opportunities to all individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We also provide reasonable accommodations to individuals with disabilities in the job application process. If you need assistance or an accommodation due to a disability, please contact us at 1-855-471-2255.