FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development

FUJIFILM Cellular Dynamics, Inc is recruiting for the role of Quality System Manager working out of our offices in Madison, WI to provide management and leadership to the FCDI’s quality systems. This role administers the development and implementation of the Quality Management System (QMS) to support (FCDI) operations, ensuring its compliance with applicable regulations and guidelines.  You will create quality metrics to support FCDI in allocating resources and priorities to fulfill quality objectives.  In addition, you will play a key role in creating and maintaining a culture of quality, compliance, safety, service, and cost initiatives.

Essential Job Functions

1. Administer the implementation and maintenance of quality assurance systems, ensuring compliance to site and corporate policies, applicable regulations and providing strategic and technical input for standard and best practices for regulatory compliance.
2. Manage Quality Systems personnel to ensure necessary support of manufacturing operations and quality control to meet compliance and business expectations.
3. Create and generate quality metric report for the FCDI site that will be used to allocate resources and priorities to meet quality objectives.  Additionally, utilize quality metrics to drive results in the FCDI QMS.
4. Manage the generation, review (as needed), and archival of documents and records used to support Good Manufacturing Practice and Discovery Research Operations.
5. Oversee quality system processes such as CAPA, complaint, investigation, internal audit, and deviation, supporting timely resolution of these records to meet compliance and business expectations.
6. Oversee quality system training program, supporting comprehension and compliance of procedures throughout cross functional areas at the site.
7. Develop, implement, and manage the internal audit program.
8. Write, revise, and approve standard operating procedures.
9. Make data driven and technical decisions that support compliance and site quality policy.
10. Select, develop, motivate, and retain a competent staff to support the quality management systems.
11. Participate in regulatory inspections and/or external client audits.
12. Other job functions as assigned.

• Bachelor’s degree in a scientific discipline or equivalent.
• 5 years of relevant experience, to include biologics experience, managing a quality assurance function within a cGMP environment with demonstrated experience in overseeing product quality from clinical supply to commercial manufacturing.
• Demonstrated ability to work concurrently in a regulated and non-regulated environment.
• Functional understanding and experience with aseptic processing and the technologies used to support it including sterility assurance, environmental monitoring, contamination control and facility design and layout (classification schemes).
• Demonstrated communication, organization and project management skills.
• Working knowledge of cGMPs and regulations including experience hosting or facilitating regulatory inspections and client audits.
• Proficiency with MS Office suite of products.
• Function experience utilizing a eQMS solution.
• Ability to travel – 10%

FUJIFILM Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.