Director of Quality Operations

6 days ago


College Station, Texas, United States FUJIFILM Corporation Full time
Job Title: Director Quality Operations

Fujifilm Corporation is seeking a highly skilled and experienced Director of Quality Operations to join our team. As a key member of our 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 for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
  • Establish operational tier structure to ensure the site is continuously complying with standard operating procedures, processes, regulatory requirements, and partner commitments.
  • Lead the Quality Operations team to deliver exceptional performance of each assigned area, including readiness activities before manufacture, oversight activities during manufacture, and review activities after manufacture.
  • Perform QA review and approval of deviations, CAPAs, and change controls.
  • Identify and implement best practices to improve right first time (RFT) execution.
  • Disposition products that meet all requirements on time based on established 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.
  • Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
  • Provide expert guidance and interpretation on procedural requirements.
  • Recruit, hire, and manage the team in line with Fujifilm Corporation policies and practices.
  • Ability to serve as deputy for VP Quality.
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 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 within CDMO
  • Advanced Degree

Fujifilm Corporation is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500.



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