Senior Quality Operations Director

2 weeks ago


Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Job Summary:

The Senior Director Quality Operations is responsible for ensuring the site's compliance with CGMP regulatory requirements. This includes leading the Quality Operations organization to create a strong quality culture, overseeing QA on-the-floor activities, batch record review, and product disposition.

Key Responsibilities:
  • Develop and implement QA oversight activities to meet all CGMP regulatory requirements.
  • Establish an operational tier structure to ensure continuous compliance with standard operating procedures, processes, and regulatory requirements.
  • Lead the Quality Operations team to deliver exceptional performance in each assigned area, including readiness activities before manufacture, oversight during manufacture, and review after manufacture.
  • Perform QA review and approval of deviations, CAPAs, and change controls.
  • Identify and implement best practices to improve right first time execution.
  • Liaise with internal and external stakeholders to achieve expected business outcomes.
Required Skills & Abilities:
  • Strong understanding of Quality Systems and cGMP regulations.
  • Excellent written and oral communication skills, with the ability to set personal performance goals and provide input to departmental objectives.
  • Strong organizational, analytical, data review, and report writing skills.
  • Ability to multitask and prioritize work effectively.
  • Proficient in Microsoft Excel, Word, and PowerPoint.
  • Able to build and maintain effective relationships with key stakeholders.


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