QC Laboratory Group Manager

Japan, Sagamihara

QC Laboratory Group Manager, Japan

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The QC Laboratory (QCL) Group Manager is responsible for ensuring and providing a safe work environment to the staff in the execution of their work duties.  Works on assignments that are non-routine in nature where ability to recognize deviation from accepted practice is required.  Works on problems of advanced technical scope in which analysis of situation or data requires a review of identifiable factors.

As QCL Group Manager, you will supervision of all chemical and microbial techniques with regards to the testing of incoming raw materials and product release also responsible for the management of the QCL Group to ensure the compliance with regulations / requirements.

Key responsibilities:

Responsible for a QC Laboratory area. Manage the daily activities of a team with responsibility for the effective testing of materials and products. Support global Laboratory investigations, studies, qualifications, validations and color development.

  • Perform QC test as required
  • Supervise the Laboratory resources to perform all required inspection and testing of raw materials and finished goods to meet business needs
  • Ensure Quality Control test methods, lab equipment maintenance / repair, calibrations and record keeping are done in accordance with established procedures
  • Schedule group plans to ensure compliant handling and timely quality control testing, method validation / qualification, and reports
  • Manage, review, and approve OOS (Out of Specification) /deviation investigations, change controls and CAPA
  • Implementation of robust laboratory management systems,  continuous improvement and enhancement of existing systems in a coordinated effort to reduce deviations
  • Establish and review the quality specifications of raw materials / other materials used for products
  • Resolving personnel issues and workplace conflicts
  • Ensure compliance with global and local regulations / standards such as GMP / QMS, IPEC and ISO
  • Implement Global projects as a local project leader
  • Support approval or rejection of raw materials and final product based on testing results/investigations
  • Support global Laboratory investigations, studies, qualifications, validations and color development
  • Support customer audits, BoH (Board of Health) interactions and Certified body audit as required
  • Ensures a safe work environment for employees to perform their duties
  • Perform any other duties as assigned by your manager

Key requirements:

  • Bachelor degree and / or advanced graduate degree in Pharmacy(preferred),  Chemistry, Biology or equivalent Science Field
  • Pharmacist (preferred)
  • At least 5 years of work experience in a pharmaceutical, chemical, cosmetic or food manufacturing site
  • At least 5 years of work experience as management (manage staffs, budget and organization)
  • Knowledge of GMP / QMS, IPEC, ISO, other regulations / standards
  • Knowledge of qualifications and validations
  • Knowledge of Data Integrity
  • Knowledge of QTS(TW), LIMS, SAP
  • Good Written & Oral Communication skill in Japanese (fluent level) and English (business level)
  • Skilful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, PowerPoint, etc).

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R37598