QMS Manager / Biopharma (Tokyo)

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United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Position: QMS Manager

Location: Tokyo

Department: HC-GM-QCQ Quality Japan

Report to: Head of Quality Japan

Direct report: 0

Your Role

The Quality Manager with Distribution Activities is responsible to define the strategy for implementing a Quality Management System (QMS) at the subsidiary.

The Quality manager is accountable for the quality and GQP/GMP/GDP/GCP compliance of:

• Act as process owner for Regulatory management in Quality Assurance department
• Manage FMA and GMP inspections and other HA interactions
• Take active role to build regulatory intelligence and deploy by monitoring, analyzing, and reporting on changes of relevant regulatory and compliance information
• Regulatory training for internal and external stakeholders
• Proactively identify and communicate areas for quality and regulatory improvement
• Act as process owner for Supplier management in Quality Management System (QMS) at the company 
• Develops and documents standard processes, focus on implementing harmonized global processes.
• Ensure the compliance and efficiency of the Quality Systems for the above-mentioned systems
• Ensure that the Change Control and Quality Risk Management systems are implemented consistently, effectively, and timely through the company’s network
• Ensure reporting and escalation of identified risks
• Identify trends, analyze, and provide recommendations and action plans on how the Quality Standards, Systems or Products should be modified or improved
• Contribute to the continuous improvement and the implementation of the global standards and procedures for the key quality processes of quality management system, through a collaborative approach with sites, subsidiaries and global functions.
• Contribute at various levels to different improvement projects, such as the future e QMS Local QA activities and quality systems in place, and maintained
• Training of local personnel on locally implemented quality systems and GMP/GDP /GQP/GCP matters (training program, training record)
• Implementation and management of quality documents including review and approval of quality documents
• Ensure corrective and preventive actions are defined in a timely manner, documented, tracked and closed in order to improve continuously the quality of the quality processes.
• Act as a local Quality Learning Coordinator (as applicable)

Who you are

Education

• Bachelor above.
• Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Medicine, Engineering or a related scientific discipline or other related field
• Background in Medicinal product distribution

Job Specific Competencies & Skills / Work Experience

• Preferably >7 years' Manufacturing/Regulatory/ QA operations(must to have), Distribution Warehouse management(nice to have) or other related activities
• Proven experience in the area of regulatory compliance (GMP/GDP/GQP) and/or quality assurance systems
• Excellent understanding of pharmaceutical regulations quality management systems
• Experience in owning one of quality management systems such as Regulatory compliance and Supplier management (priority), Change Control Deviation, Risk Management, Document Management, and Training
• Experience in working with multiple competing stakeholders and priorities
• Ability to successfully manage multiple critical issues simultaneously
• Good time and priority management skills
• Ability to prioritize and work in a rapidly changing environment.
• Willingness and enthusiasm to learn and share knowledge
• Excellent negotiation and influencing skills, highly desired but not essential

Languages

• Native level in Japanese. Fluent in spoken and written English

Additional Requirements

• Ability to travel nationally and internationally (Not often. 1 or 2 times per year only when needed)

• Knowledge/experience of GQP / GMP/GCP Ordinances from MHLW and ISO standards
• Computer skills (Teams, Word, Excel, SharePoint, etc.)
• Basic Project Management and related tools skills, highly desired but not essential

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!