Cheryl C. Email & Phone Number

Madison, Wi, Us

Madison, Wi

Responsible for designing, developing, and implementing a quality system for the IT department. This involves harmonization with other sites and integration with the corporate QMS.

Verona, Wisconsin

Responsible for maintaining and improving the validation program by proposing strategic direction based on current regulations and industry standards for validation, change control and data integrity.

Madison, Wisconsin Area

Provided strategic direction and oversight of Quality Assurance, Quality Control, and Metrology functions at the Madison, WI and Novato, CA sites for the Cell Therapy and Life Sciences business divisions. Managed the departmental budget and developed staffing plans to meet the company’s revenue goals. Worked collaboratively with employees of FujiFilm from around the world on projects to modernize and scale up manufacturing and gain overall efficiencies. Began work to develop GMP systems suitable for Phase 1 manufacturing.

Madison, Wisconsin Area

Designed, developed and implemented a quality system to ensure compliance with FDA, OECD, and MHLW GLPs while the company was in it's formative years. Responsibilities entailed, writing SOPs, data archival, document control, software validation, hosting sponsor audits, managing and implementing the GLP Training program, and monitoring CDI’s quality systems, facilities, vendors, laboratory, and studies through audits and inspections.

Middleton, Wi

Ensured software, equipment, methods, and processes met current FDA guidelines. QA rep for pre-clinical studies as well as cross-functional teams created to transfer drug substance and parenteral manufacturing processes.