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Quality Standards Integration Specialist
1 week ago
Johnson & Johnson is a global healthcare leader, committed to improving the lives of people around the world. We are driven by our passion for innovation and our commitment to putting patients first.
About the RoleWe are seeking a Senior Project Manager, Quality (Emerging Standards and Regulations Integration) to lead the assessment and implementation of major standards and regulations at J&J MedTech businesses. This role will require the ability to independently evaluate standards and regulations, influence partners in the business, and lead contract resources.
The successful candidate will be responsible for developing a coordinated plan to implement standards and regulations, leading the assessment and implementation of external standards and regulations, implementing governance for strategic priority objectives, and leading budget planning and maintenance for projects.
This position requires a strong understanding of regulatory requirements, including EU MDR and FDA regulations, and their impact on Quality Management Systems and associated processes. The ideal candidate will have outstanding written and verbal communication skills, as well as strategic problem-solving and leadership abilities.
Responsibilities- Develop a coordinated plan to implement standards and regulations in alignment with internal and external partners.
- Lead the assessment and implementation of external standards and regulations.
- Implement governance for strategic priority objectives - engage with executive sponsors and key partners, developing regular communications.
- Lead budget planning and maintenance for projects.
- Drive risk identification, management and plans for resolution.
- Responsible for hiring and management of program level resources including partnering with consultant/contractor resources.
- Inspire Change & Communication strategies.
- Lead team meetings, with accountability for agenda & content management.
- Responsible for presenting business related issues to next management level.
