Quality Systems Director

3 days ago

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

**Job Description Overview**

The Director of Quality Systems is responsible for driving the development, implementation, and maintenance of individual sub-systems within the Pharmaceutical Quality Systems (PQS) framework at Fujifilm Diosynth Biotechnologies (FDBT). This role entails overseeing one or more PQS sub-systems, including Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, e QMS, and Quality Management.

As a key leader, you will guide your assigned team in fostering a strong quality culture that promotes engagement, motivation, and collaboration among staff. Your role involves establishing and maintaining strong working relationships with internal and external stakeholders to ensure the site's PQS sub-system aligns with the harmonized global FDB PQS, organizational goals, and areas of continuous improvement.

**Essential Functions:**

  • Develop, implement, and maintain risk-based PQS sub-systems that meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
  • Establish governance and oversight processes to guarantee compliance with site and global quality standards, regulatory requirements, and partner commitments.
  • Lead the Quality Systems team to deliver exceptional performance of each assigned sub-system.

**Key Responsibilities:**

  • 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.
  • Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
  • Provide expert guidance and interpretation on regulatory requirements.
  • Recruit, hire, and manage the team in line with FDBT policies and practices.
  • Ability to serve as deputy for Senior Director Quality Systems.

**Requirements:**

  • Expert understanding of Pharmaceutical Quality Systems.
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review, and report writing 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.
  • Ability to work independently with little supervision.
  • Proficient in Microsoft Excel, Word, and PowerPoint.

**Qualifications:**

  • Bachelor's degree with 10 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment;
  • OR Associate's degree with 12 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment;
  • At least 6 years of experience in a supervisory or managerial role;
  • A minimum of 5 years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.

**Preferred Qualifications:**

  • Experience with biologics – vaccines, gene therapy, mAb, etc.
  • Experience within CDMO
  • Advanced Degree ASQ Certification

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