Quality Assurance Director

3 weeks ago


TX United States Fujifilm Diosynth Biotechnologies Full time
Director Quality Operations Job Description

Fujifilm Diosynth Biotechnologies is seeking a highly skilled Director Quality Operations to join our team. As a key member of our quality organization, you will be responsible for ensuring the highest standards of quality in our manufacturing operations.

Key Responsibilities:
  • Develop and implement quality oversight activities to meet all CGMP regulatory requirements.
  • Establish operational tier structures to ensure compliance with standard operating procedures, processes, and regulatory requirements.
  • Lead the Quality Operations team to deliver exceptional performance and achieve business objectives.
  • 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.
  • Partner with Quality Compliance to ensure the site is inspection ready at all times.
  • Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
Requirements:
  • 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.
  • 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 within CDMO
  • Advanced Degree

Fujifilm Diosynth Biotechnologies is an equal opportunity and affirmative action employer. We are committed to creating a diverse and inclusive work environment. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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