Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
QualityJob Sub Function:
Supplier QualityJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob Description:
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Role:
Account owner and subject matter expert for API, excipient, packaging material and manufacturing material suppliers located in Japan and related materials. Responsible for the supplier quality lifecycle management (selection, qualification, audit handling, monitoring, risk management, change control management, complaints handling, escalations, etc.)
Quality and Compliance lead, ensuring quality standards are achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners.
This position may lead high impact projects and optimization initiatives at both the regional and global level.
Provide support to local manufacturing sites during customer, regulatory compliance, and health authority inspections as needed.
Qualifications
Experience:
A minimum of 10 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with proven experience in managing external manufacturing operations or Quality Assurance for external manufacturing.
Travel: Up to 15% local travel expected
Competency / skill requirements:
- Familiarity with GMP – and International Conference on Harmonization ( ICH ) - regulations
- Auditor certification for Pharmaceutical or Medical Devices industry is preferred
- Experience working with API, excipient, packaging material, and manufacturing material suppliers located in Japan
- Strong stakeholder management skills and experience working with different functional groups in supply chain
- Good written and oral communication skills in both Japanese and English.
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