Quality Management Systems Operations Manager
4 weeks ago
Johnson & Johnson is seeking a highly skilled Quality Management Systems Operations Manager to join our team. As a key member of our Quality Systems organization, you will be responsible for overseeing the operations of our Quality Management Systems (QMS) and ensuring compliance with regulatory requirements.
Key Responsibilities:- Develop and implement quality metrics and reports to support Quality Management Review and operational QMS meetings.
- Review and optimize key quality metrics to drive continuous improvement and sustain technology systems compliance.
- Provide QMS oversight and services for J&J Technology Services (JJT-TS) quality elements as assigned by the Director of QMS.
- Establish and maintain quality assurance standards, adhering to GxP practices, Quality System, and ISO regulations.
- Own and implement novel process improvement projects within QMS elements to drive exceptional results and sustain compliance.
- Support and lead inspections, including communication and coordination with J&J corporate organizations and Health Authorities as required.
- 8-10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Healthcare Technology activities.
- Strong experience in managing analytics and visualization tools/systems, such as Tableau, Alteryx, and BI tools.
- Advanced proficiency in skills including Data Integrity, Testing, Quality Management Systems.
- Experience with management of Quality Management Systems elements.
- Experience in quality risk management.
- Strong understanding of Global and Regional GxP Regulations, including FDA Quality Systems and ISO 13485.
- Working knowledge of Agile, PMO, SDLC, GAMP 5, and ITIL frameworks.
- Experience with Six Sigma/Process Excellence tools, training, and certification.
- Certified Software Quality Engineer (CQSE).
- Certified Quality Engineer (CQE).
- Project Management Professional (PMP).
- Competitive salary range: $120,000 - $207,000 USD.
- Annual performance bonus.
- Comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Time off benefits, including vacation, sick time, holiday pay, and personal and family time.
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