Quality Systems Manager

Johnson & Johnson

Wilson, North Carolina, United States of America
Quality management systems
Regulatory compliance
Gmp, ich, and iso standards
Lead the Quality Systems team and ensure implementation and maintenance of robust quality management systems to support manufacturing processes and adhere to regulatory requirements

Job Summary

  • Lead the Quality Systems team and ensure implementation and maintenance of robust quality management systems to support manufacturing processes and adhere to regulatory requirements.
  • Responsible for the site’s Management Review program, Quality metrics program, and driving a culture of quality throughout the organization.
  • Support the construction, operational start-up, and end state of the DS site operations in Wilson, NC, with a focus on innovative biologic medicines.

Matching Summary

Lead the Quality Systems team and ensure implementation and maintenance of robust quality management systems to support manufacturing processes and adhere to regulatory requirements.

Skills & Requirements

Must-have

  • Quality Management Systems
  • Regulatory Compliance
  • GMP, ICH, and ISO standards
  • FDA and EMA guidelines
  • Health authority interactions
  • Nonconformance and CAPA management

Nice-to-have

  • Continuous improvement mindset
  • Proactive quality management
  • Cross-functional collaboration
  • Results-driven leadership

Key Requirements

  • Bachelor's degree in scientific or engineering
  • 6+ years in biological/pharmaceutical industry
  • Experience with regulatory inspections
  • People management experience in Quality
  • Experience in supporting functional area

Work Rights

Not specified

Tailored Resume

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