SR Manager, Quality Management Systems Operations
Publication date:
04 October 2024Workload:
100%Contract type:
Permanent position- Place of work:Johnson
Johnson & Johnson is recruiting for a Senior Manager of Quality Management Systems (QMS) Operations! This position can be performed at any J&J Site in North America, with a preference for Raritan, NJ.
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/.
Position Summary:
Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that supports QMS Management and Commercial Quality Shared Services. This organization has a focus on new and innovative technologies and implementing the appropriate quality controls for the determined risk profiles.
As the Senior Manager of QMS Operations, you will have the unique opportunity to oversee the operations of the Johnson & Johnson's Technology Services QMS. This role will have a primary focus on the ownership, management and coordination of the quality metrics required for GxP decision making. Operational support may also be required for innovative analysis and oversight of QMS elements processes such as Quality Planning, CAPA, Document Management, Training Management, Supplier Management, SDLC/Validation, and Product and Non-product Security. Your role will be critical in ensuring that the QMS is flawless, world-class, and adheres to GxP requirements and ISO regulations while consistently implementing continuous enhancements.
Key Responsibilities
- Responsible for delivery of the QMS metrics, reports, and dashboards in support of Quality Management Review, operational QMS meetings, and periodic updates as applicable.
- Review and optimize key quality metrics to create opportunities for increased success and implementation of those changes.
- Develops and reports on key quality metrics to drive continuous improvement and sustain technology systems’ compliance.
- Provides QMS oversight and services for the J&J Technology Services (JJT-TS) quality elements as assigned by the Director of the QMS
- Establishes and maintains quality assurance standards, which adhere to GxP practices, Quality System and ISO regulations. Responsible for communicating business related issues or opportunities to next management leve
- Own and implement novel process improvement projects within the QMS elements to drive exceptional results, continuous improvement and sustain compliance.
- Develop an analytics framework and lead projects as needed to sustain compliance
- Supports & leads inspections including communication and coordination with J&J corporate organizations and Health Authorities when required
- Provide an environment which encourages the company’s credo and the value of a diverse workforce
People Management
- Identifies critical skills and capabilities required to ensure the development of a highly skilled, high performing QMS
- Support the development of indirect reports including training and mentoring to meet current and future business needs
- Works with Quality Operations leadership and pillar leaders to nurture future leaders and create opportunities to grow
- Mentors talent and helps them grow in their careers