Senior Director of Quality Assurance

2 weeks ago


Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Company Overview

Fujifilm Holdings America Corporation is a leading global manufacturer of innovative products. We are committed to advancing tomorrow's medicine by driving innovation, passion, and excellence in our employees.

Job Description

The Director of Quality Compliance will be responsible for developing and implementing individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FUJIFILM Diosynth Biotechnologies. This role will lead the assigned team to create a strong quality culture, ensuring the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals, and objectives.

Responsibilities:

  • Develop, implement, and maintain risk-based PQS sub-systems to meet all CGMP regulatory requirements.
  • Establish governance and oversight processes to ensure compliance with site and global quality standards, regulatory requirements, and partner commitments.
  • Liaise with internal and external stakeholders to achieve expected business outcomes.
  • Partner with Quality Compliance to ensure the site is inspection-ready at all times.
  • Implement audit/inspection learnings within the site QMS; share learnings between FDB sites.

Requirements:

  • Expert understanding of Pharmaceutical Quality Systems.
  • Excellent written and oral communication skills.
  • Ability to set personal performance goals and provide input to departmental objectives.
  • Develop staff to maximize contributions to the team and the company.
  • Ability to multitask and easily prioritize work.


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