About the position
The Senior Director Quality Systems at FUJIFILM Diosynth Biotechnologies (FDB) is a pivotal role responsible for the development, implementation, and maintenance of the Pharmaceutical Quality Systems (PQS). This position is crucial in fostering a strong quality culture within the organization, ensuring that the Quality Systems team is engaged and motivated while maintaining robust relationships with both internal and external stakeholders. The Senior Director will oversee various quality subsystems, including Deviation, CAPA, Change Control, Supplier Quality, Document Control, QA Validation, eQMS, and Quality Management, ensuring alignment with the global FDB PQS and continuous improvement initiatives. In this role, the Senior Director will develop a risk-based PQS that meets all CGMP regulatory requirements for clinical and commercial drug substance and product manufacturing. They will establish governance and oversight processes to ensure compliance with site and global quality standards, regulatory requirements, and partner commitments. The Senior Director will lead the Quality Systems team to deliver exceptional performance across all assigned subsystems and will liaise with stakeholders to achieve desired business outcomes. Additionally, they will partner with Quality Compliance to ensure the site is always inspection-ready and will implement learnings from audits and inspections into the site QMS, sharing insights across FDB sites. The Senior Director will also be responsible for identifying areas of risk and opportunities for continuous improvement, providing expert guidance on regulatory requirements, and managing the recruitment and development of the Quality Systems team. This role may also require serving as a deputy for the VP of Quality, ensuring that all duties are performed in line with FDBT policies and practices.
Responsibilities
- Develop, implement, and maintain the risk-based Pharmaceutical Quality Systems (PQS) to meet CGMP regulatory requirements.
- Establish governance and oversight processes to ensure compliance with quality standards and regulatory requirements.
- Lead the Quality Systems team to deliver exceptional performance across all assigned subsystems.
- 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 and share learnings between FDB sites.
- Identify areas of risk and continuous improvement; escalate and communicate as appropriate.
- Provide expert guidance and interpretation on regulatory requirements.
- Recruit, hire, and manage the Quality Systems team in line with FDBT policies and practices.
- Serve as deputy for the VP Quality as needed.
Requirements
- Bachelor's degree with 12 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR Associate's degree with 14 years of relevant experience.
- At least 8 years of experience in a supervisory or managerial role.
- A minimum of 7 years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
- Expert understanding of Pharmaceutical Quality Systems.
- Excellent written and oral communication skills.
- Strong organizational, analytical, data review, and report writing skills.
- Ability to set personal performance goals and contribute to departmental objectives.
- Proficient in Microsoft Excel, Word, and PowerPoint.
Nice-to-haves
- Experience with MasterControl, Veeva, Blue Mountain, SAP, and Trackwise.
- Experience within a Contract Development and Manufacturing Organization (CDMO).
- Advanced Degree.
