Director of Quality Operations
4 weeks ago
Overview:
The Director Quality Operations-Shared Services will play a critical role in ensuring the quality and compliance of our manufacturing operations. This individual will be responsible for leading the Quality Operations team to create a strong quality culture, maintaining strong working relationships with internal and external stakeholders, and ensuring products are manufactured to meet all CGMP regulatory requirements.
Key Responsibilities:
- Develop and implement QA oversight activities to meet all CGMP regulatory requirements.
- Establish operational tier structure to ensure compliance with standard operating procedures, processes, and regulatory requirements.
- Lead the Quality Operations team to deliver exceptional performance in each assigned area.
- Perform QA review and approval of deviations, CAPAs, and change controls.
- Identify and implement best practices to improve right first time 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.
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:
- At least 5 years of direct experience in some or all these areas: drug product, raw materials, warehouse, analytical, buffer/media, cell banking.
- Experience within CDMO.
- Advanced Degree.
About FUJIFILM Corporation:
FUJIFILM Corporation is a global leader in the development and manufacturing of innovative technologies. We are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are 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.
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