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Quality Operations Director
Requisition ID: 1805652689W
- Policies: Know & follow 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
- Design, develop, implement, maintain and continuously improve JJMSZ Quality Systems to support the business strategies and the release of marketed products, meeting standards, regulations and customer requirements. The Quality System should permit seamless integration with other MD&D Franchise Quality Systems within Johnson & Johnson Medical (Suzhou) Ltd. with the aim of creating a single Quality System for the MD&D campus.
- 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 JJMSZ site Quality System 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 JJMSZ. To analyse these measurements and to identify the most significant issues and prioritize for action. To lead, sell and implement improvement opportunities and problem solutions.
- Represent JJMSZ Quality and Compliance function on relevant company, corporate or industry projects team or committees as required.
- Represent China Management during Regulatory Inspections. Secure required regulatory approvals for site to permit Global market availability of internally manufactured and designed products.
- Support Regulatory staff to prepare the relevant Manufacturing and Quality dossiers required for Design History Records for new or transferred product.
- Manage the quality resource for JJMSZ.
- Provides coaching, useful feedback and direction to direct reports and team.
- Develop organizational depth to meet present and future needs.
- At a minimum, BS degree in Engineering or related scientific / statistical discipline required.
- Minimum 7 years’ experience in a medical device, pharmaceutical or similar regulated industry
- Five (5) years of active management experience including direct supervision and matrix management.
- Process Excellence and Lean experience or equivalent combination of training and experience.
- Ability to independently analyze data, identify trends and formulates improvement plans
- Strong communication, influencing and leadership skills. Ability to communicate at all levels of the organization.
- Proven Change Management Skills
- Initiative in innovative approaches to Quality Management & Quality Engineering solutions and applications in a fast-paced changing business environment.
- Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, Pre-production Quality as well as good working knowledge of related functions such as operations, sterilization/microbiology and product development.
- Expert knowledge of Good Manufacturing Practices, regulations and validation methods
- Quality assertiveness and quality mindedness
- Extensive experience with ISO 13485/QSR standards
- Self-managed-works independently to set goals and monitor performance
- Analytical & creative thinking
- Strong problem-solving skills and able to set priorities in a complex and constantly changing environment.
- Organizational -can synthesize information from a variety of sources
- Experience managing audits -against ISO (International Organization for Standardization), QSR (Quality Systems Regulations) & GMP (Good Manufacturing Practices) standards
- Mobile for domestic and worldwide business trips
- Serve as a role-model for making Credo based decisions
- Create cross-functional partnerships and connections to rapidly address challenges
- Communicate the importance of change and transformation to your teams and enterprise success.
- Create an environment where leadership and talent development is a top priority.
- Develop a culture of accountability
- Build an environment supportive of diverse and inclusive thinking and perspectives
- Differentiating Competencies
- Sense of Urgency
- Understanding of operating in a global matrix environment
- Ability to think with an enterprise-wide mindset
- Challenge the status quo; bring in new ideas and innovation
- Specific Technical Skills Required
- Problem Solving
- Risk Management
- QSR/ISO 13485
- Operations Processes
- Systems Development & Integration
- Business Acumen
- Travel approximately 20% of the time.
Johnson & Johnson Medical Suzhou Ltd. (7054)