Regulatory Compliance Manager

4 days ago


Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Key Responsibilities

The Regulatory Compliance Manager will be responsible for ensuring our products comply with relevant regulations. This includes developing and implementing Quality policies, procedures, and processes.

Primary Responsibilities:
  • Review and approve documentation, including Standard Operating Procedures, Batch Production Records, and Commissioning, qualification and validation protocols and reports.
  • Draft and review internal Quality policies, procedures, and reports.
  • Conduct Quality audits to ensure adherence to national and international standards and regulations.
  • Identify opportunities for process and Quality System improvements.
Requirements:
  • High school or equivalent and 8+ years' experience in Pharmaceutical or other regulated Industry.
  • Associates Degree and 5+ years' experience in Pharmaceutical or other regulated Industry.
  • Bachelor's degree and 3+ years' experience in Pharmaceutical or other regulated Industry.
  • Master's Degree and 1+ years' experience in Pharmaceutical or other regulated Industry.
  • Certified Quality Auditor preferred.


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