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Director of Quality Operations
1 month ago
Overview:
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 leading the Quality Operations organization to create a strong quality culture of engaged and motivated staff. You will maintain strong working relationships with internal and external stakeholders, ensuring products are manufactured to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
Key Responsibilities:- Develop, implement, and maintain QA oversight activities to meet all CGMP regulatory requirements.
- 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.
- 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 FDBT policies and practices.
- Ability to serve as deputy for VP Quality.
- Bachelors degree with 10 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR
- Associates 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.
- 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.
