Overview
The Senior Quality Systems Manager provides leadership and oversight in Japan quality and compliance efforts. The person also supports business operations and ensure compliance with MHLW & PMDA regulations and ISO standards.
Responsibilities
- Maintain and improve the site Quality Management System (QMS) effectiveness and compliance with global and local regulatory (ie Japan Pharmaceutical Affairs Law) requirements.
- Management of external and internal audits or inspections program to ensure its effectiveness.
- Maintain and improve the site training and education program ie by ensuring an efficient Learning Management Systems (LMS) and meet applicable standards/requirements.
- Ensure compliance of Waters Japan products and processes with the Quality Agreement between Waters Japan and legal manufacturers.
- Routinely perform compliance assessments on processes, procedures and regulations to identify potential gaps and implement improvements.
- Support site leadership team to achieve Waters Japan Commercial Operations objectives.
- Represent Waters Japan in regional, global and/or cross functional teams, projects and initiatives.
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Qualifications
- Bachelor's degree in areas such as engineering, life sciences and chemistry.
- Minimum 10 years of experience in the commercial medical device, diagnostic products or pharmaceutical industry of which minimum 5years in managerial position.
- Proven experience in supporting or leading third party audits (ISO registrars, PMDA or other regulatory authorities).
- Minimum 5years of QMS Lead Auditor experience.
- Good understanding of PMD Act, relevant regulations and guidelines.
- Able to collaborate effectively with local and global stakeholders to deliver expected results to Waters.
- Able to work efficiently with minimum supervision.
- Able to work within a matrix organization with personnel in global locations.
- Languages: Native Japanese, Fluent English - spoken and written.
Company Description
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.