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Quality Assurance Manager / Life Science Services_Life Science (Yokohama)
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
The Quality Manager II is responsible for sustaining and improving our Quality Management system per ISO 9001, Life Science and our corporate requirements. The Quality Manager is responsible to leading and developing the site Quality team in accordance with our corporate values and industry best practices. The Quality Manager works in collaboration with the site Operations team to fulfill all customer requirements and reports directly to the Head of Quality, Validation Services. This includes: Taking accountability for the effectiveness of the QMS; ensuring that the quality policy and quality objectives are compatible with the context and strategic direction of the organization, and known to all in the organization; ensuring the integration of QMS requirements into the organization’s business processes; ensuring that the resources needed for the QMS are available; communicating the importance of effective quality management; engaging, directing and supporting persons to contribute to the effectiveness of the QMS.
Who you are:
- Bachelor’s Degree in Biology, Chemistry or related science
- 5 years’ experience in a leadership position in an ISO 9001 environment
- Extensive knowledge and application of ISO 9001 management systems
- Lead auditor or other quality related certification (ASQ or equivalent)
- Expert technical writing skills
- Experience in a GMP regulated environment
- In depth understanding of data integrity (as per 21 CFR part 11)
- Experience in developing and maintaining Key Process Indicators (KPIs)
- Experience in applying problem solving tools (fishbone, 5 Whys, 8D, FMEA etc.)
- Understanding and application of Statistical Process Control (SPC)
- Lean / Six Sigma certification and application
- Strong computer application skills (MS Teams, Excel, Project, PowerPoint, SharePoint)
- Strong written and oral communication skills
- Experience in leading and responding to customer audits /audit findings
- Experience developing and leading a team in a collaborative, fast paced environment
- Values based approach to work
- Curiosity and drive to succeed: individually and as a team; willingness to learn and lead by doing
・Office location is Yokohama, Kanagawa
・Flexible work style available (Remote work 2~3 days/week)
・Open work environment and flat organization.
Recruiting Contact: Maiko Yamasue
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com