Director of Quality Assurance Operations

5 days ago


Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Position Overview

The Senior Director, Quality Operations will lead the site's quality operations organization to create a strong quality culture. This role is responsible for QA oversight of cGMP operations and areas at one of the manufacturing facilities, or the Quality Control unit. The ideal candidate will have experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.

The work we do has never been more important—and we are looking for talented candidates to join us. We cultivate a culture that fuels your passion, energy, and drive.

Job Description
  • Main Responsibilities:
  • Develop, implement, and maintain QA oversight activities to meet all cGMP regulatory requirements.
  • Maintain an operational tier structure to ensure compliance with standard operating procedures, processes, regulatory requirements, and partner commitments.
  • Lead the Quality Operations team to deliver exceptional performance of each assigned area.
  • 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.


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