- Entry level
- No Education
- Salary to negotiate
Provide subject matter expertise facilitating the business proposal and technical evaluation and supplier management process to fulfill market specific solutions needs in JJKK and ASPAC region.
Operate as a key business partner for quality and process improvement, understand business requirements and execute market specific solutions to drive organization capability building.
Work with source operating companies to implement respective Quality System responsibilities and assure appropriate communication channels are created and maintained.
Leverage knowledge, resources to transfer or scale up J&J proven quality programs and process in JJKK and within the region.
Support compliance to all J&J Quality Policy and Technical Standards and regulatory requirements where applicable.
Development and monitor the appropriate product and process performance measures/targets.
Participate, support or lead APR process and quality improvement project when applicable.
Communicate and engage commercial leaders, champions, process owners and project teams about applying BQ processes and procedures.
Demonstrates ability to develop and implement corrective / preventative action and mitigation plan recommendations.
Explore, identity, connect and maintain network with franchise SMEs to socialize, learn and align applicable J&J quality and compliance requirement
Communicate and partner with JJKK and other LOC stakeholders (QRC, commercial, process owner etc) to execute the applicable requirement.
Supplier management process.
MHLW process on pre-market product registration and post market surveillance process, MAH responsibility and MD Good Distribution Process.
Familiar with international or Japan Industrial standards
Local Market Acumen
The ability to understand and adhere to key local market compliance standards to meet quality requirements and market needs, such as product licensing & authorizations, labeling regulations, repackaging / relabeling procedures, local market promotion / marketing compliance, etc.
Demonstrate ability on succinct and clear communicate with commercial and business partner .
Demonstrates ability to work in a matrix reporting and cross-cultural environment
Bachelors or master’s degree in Biosciences or Engineering or equivalent field
Relevant experience in the regulated industries in product design, development or transfer, or manufacturing environment or APR process.
Technical knowledge or experience in sterility, computer system validation etc.
Experience with project management.
Influence and interact at multiple levels of the organization.
Ability to manage multiple priorities and deliver excellent results.
Excellent written and verbal communications skills.
ISO13485 or equivalency lead auditor qualification
Johnson & Johnson K.K. (8235)
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.