Johnson & Johnson Careers
J&J Medical Devices Quality Operations Senior Director, Asia Pacific
Requisition ID: 1805678164W
- Responsible for the overall quality execution and operations of J&J MD manufacturing sites in Suzhou and Minhang, China, and Sukagawa, Japan. This role will also be responsible to oversee the critical transfer of existing supply chain value streams to local markets, as well as providing business continuity to our worldwide operations.
- This position is responsible to define, document, implement and maintain fully integrated Quality Management Systems for internal manufacturing operations in alignment with regional/franchise objectives and sector/corporate quality standards and strategies including measuring the performance of the Quality Management Systems, and directing continuous improvement efforts.
- Will develop and maintain compliance and certifications to all applicable regulatory standards required for global distribution of products manufactured at the sites.
- To support all third-party audits (eg. CFDA, FDA, Notified Body, J&J corporate, etc…).
- To support and execute the integration of new businesses to the sites in alignment with the leveraged Quality System approach
- Manage reports in supporting product manufacturing and distribution efforts in JJMSZ.
- Will serve as DePuy Synthes Management Representative for the JJMSZ site.
Policies: Know & follow JJMD, JJMSZ, and Franchise policies & procedures related to work activities performed in area of responsibility and ensure compliance to quality policies site-wide by all functions
Safety: Follow all company safety policies and other safety precautions within work area. Promote safety to all associates that enter work area.
Act as Management Representative for the Quality System in JJMSZ, and as necessary JJMC Minhang and JJKK Sukagawa.
Design, develop, implement, maintain and continuously improve Quality Systems to support the business strategies and the release of marketed products, meeting standards, regulations and customer requirements. The Quality Systems must enable seamless integration with other MD Franchise Quality Systems with the aim of creating a single Quality System for JJMD.
Actively support and execute the integration of all new franchises/internal acquisitions. Activities may include (but are not limited to): due diligence, alignment of the QS shared procedures in order to meet all potential new requirements while maintaining consistency across the Campus
Use PE principles, tools and practices to develop and optimize the Quality Systems to assure all systems and processes provide a measurable impact to quality, cost and customer value.
Identify opportunities to continually improve Quality, cost efficiency and effectiveness of the Quality Management System consistent with the business objectives.
Report appropriate Quality business measurements to continually monitor the performance of the sites. Analyse data and measurements and to identify the most significant issues and prioritize for action. To lead, sell and implement improvement opportunities and solutions.
Represent JJMD and JJMSZ Quality and Compliance function on relevant company, corporate or industry projects team or committees as required.
Represent Management during Regulatory Inspections. Secure required regulatory approvals for site to permit Global market availability of internally manufactured and designed products.
Manage the quality resources sites.
Provide coaching, useful feedback and direction to direct reports and team.
- Develop organizational depth to meet present and future needs.
Johnson & Johnson Medical Suzhou Ltd. (7054)