Johnson & Johnson Careers
【Medical】Business Quality Manager
Requisition ID: 1805699622W
- 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)