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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.
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Position: QMS Manager
Department: HC-GM-QCQ Quality Japan
Report to: Head of Quality Japan
Direct report: 0
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 compliance of:
- Act as process owner for the Training management and Document management for Japan and global organization, act as a local Quality Learning Coordinator (as applicable)
- Manage the Training and Document activities including the implementation of an appropriate action plan, fostering a Quality Culture
- Implementation and management of quality documents including review and approval of quality documents
- Training of local personnel on locally implemented Quality systems
- Local Quality activities and Quality systems in place, and ensure they are maintained
- Lead the Community of Practice for Training and Document Management
- Ensure that the Training and Document systems are implemented consistently, effectively, and timely through the company’s network
- Provide a consolidated view of Document and Training, and report to Management through the periodic reviews and appropriate reports in place
- Ensure the compliance and efficiency of the Quality Systems for the above-mentioned systems
- Support and train the manufacturing sites and subsidiaries in the management of Document and Training systems whenever appropriate
- 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 eQMS Local QA activities and quality systems in place, and maintained
- 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.
Who you are
- Bdachelor 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
- Preferrably >3 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / 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 quality management systems
- Experience in owning one of quality management systems such as Training or Document mangement (priority), Risk Management, Deviation, Change Cotrol, Audit
- 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 desiered but not essential
- Continuous improvement mindset, attention to detail, organizational skills
- Native level in Japanse. Fluent in spoken and written English
- Ability to travel nationally and internationally (Not offten. 1 or 2 times per year only when needed)
- Computer skills (Word, Excel, SharePoint, etc.)
- Basic Project Management and related tools skills, highly desired but not essential
Additional Local Legislative/Country specific Requirements
- GQP / GMP / QMS/GCP Ordinances from MHLW
Recruiting contact: Fang Liu
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!
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