Senior Manager of Quality Management Systems

4 weeks ago


Raritan, New Jersey, United States Johnson and Johnson Full time
Job Summary

Johnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the highest standards of quality and compliance, and will work closely with the Director of the QMS to establish and maintain quality assurance standards.

Key Responsibilities
  • Provide QMS oversight and execution services for the J&J Technology Services (JJT-TS) quality elements as assigned by the Director of the QMS.
  • Establish and maintain quality assurance standards, which adhere to GxP practices, Quality System and ISO regulations.
  • Own and implement novel process improvement projects within the QMS elements to drive exceptional results, continuous improvement, and sustain compliance.
  • Develop and report on key quality metrics to drive continuous improvement and sustain technology systems' compliance.
  • Support and lead inspections, including communication and coordination with J&J corporate organizations and Health Authorities when required.
Requirements
  • 8-10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Healthcare Technology activities.
  • Advanced proficiency in skills including Data Integrity, Testing, Quality Management Systems.
  • Experience with management of Quality Management Systems elements with preference for Non-Conformance and CAPA.
  • Experience in quality risk management.
  • Strong understanding of Global and Regional GxP Regulations including FDA Quality Systems and ISO 13485.
Preferred Qualifications
  • 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).
Benefits
  • This position may require up to 10% domestic and international travel.
  • The anticipated base pay range for this position is $120,000 USD.

Johnson & Johnson offers a comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may also be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).



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