Mark Hutt Email & Phone Number

Lawrence Township, Nj, Us

In this position, we are responsible for driving continuous improvement of the quality system, leading initiatives to support network standardization, and harmonize processes across the Global Cell Therapy network. Additionally, our team drives the development of a strong quality culture though the establishment of mature and continuously improving quality systems.Responsible for direction and oversight of Event Management (Deviations, Product Quality Complaints, OOS-OOT), CAPA Management, Quality Risk Management, Training Management, Document & Records Management, and Change Control/Management.

Lawrence Township, Nj, Us

Responsible for the strategy, design, execution, and management of GMP training and document Quality Systems across global Cell Therapy Technical Development and Technical Operations. Also provide support for other aspects of GMP Quality Systems including deviation/CAPA, inspection management, and change control.

Seattle, Wa, Us

Responsible for the strategy, design, execution, and management of GMP training across global Cell Therapy GMP development and operations.

Basel, Baselstadt, Ch

As the Global head of GxP Training for Sandoz. In this role, we worked to advance the maturity of the Sandoz and Novartis Training Quality System and improve human and organizational performance. I was responsible for overseeing GxP and technical training for Sandoz globally, supporting 30,000+ associates in 40+ manufacturing sites, 50+ commercial operations locations, and several Sandoz Development Centers. Through the development and deployment of eLeanring (computer based), instructor lead, and blended learning solutions, we supported the development of key competencies associates in Sandoz and Novartis.In 2017 I took a Global role with Novartis focusing on the following:Led creation and implementation of Novartis-wide Global Operating Procedure for Training and Learning. Procedures cover training development, assignment, and delivery for all GxP operations in Novartis to meet all internal and external health authority requirements. Led of Improving Corrective & Preventative Action(CAPA) Effectiveness initiative to reduce human error, increase right first time, and decrease batch rejection and recall rate. Led workshops in Asia-Pacific and across Europe to improve CAPA effectiveness. Led creation and implementation of Novartis wide Trainer Qualification program. Provided Train-the-Trainer course in locations across Asia-Pacific, North America, and Europe.

Basel, Baselstadt, Ch

In this role I led the Sandoz Broomfield, Colorado Training organization. Our work focused on developing and delivering training programs, materials, and processes to successfully lead the site through a remediation process. Our work also was focused on a comprehensive cultural change initiative. Through a close partnership with Human Resources, we developed programs and solutions to improve the quality culture at the site and in the North American region. I also provided support and leadership of regional, divisional, and global Training/Human & Organizational Performance efforts for Sandoz and Novartis.

Thousand Oaks, Ca, Us

Workplace learning and performance professional with multiple site and start-up experience in manufacturing operations. My work focused on continuous organizational performance improvement at a multi-product human therapeutic manufacturing site. Work in this role focused on leading the transition from a technical training organization to a performance partnering organization focused on improving human and organizational performance.

Thousand Oaks, Ca, Us

Supported the Amgen Rhode Island manufacturing facility. Lead a team of staff in the development and delivery of training programs and performance solutions supporting the Quality, Quality Control, and site manufacturing organizations. Developed and implemented a novel solution to make data driven decisions on which training and development course to offer at the site.

Thousand Oaks, Ca, Us

Lead the Training & Development department in support of the BioNext facility start-up. Developed programs and processes for training and development of Manufacturing, Quality, Quality Control, and other functions. Lead global project to develop a four-week basic skills program for Manufacturing employees which reduced on-boarding time by 30%.

Thousand Oaks, Ca, Us

One of the first technical Training Specialist for Amgen and the first in Amgen Colorado. Developed a technical training center to allow for hands on training and the development of on-boarding and new hire training programs. Part of the acquisition team to lead the integration of the West Greenwich Immunex site into the Amgen organization.

Thousand Oaks, Ca, Us

Frontline manager for Amgen's cell culture manufacturing facility in Thousand Oaks, CA. System owner for clean-in-place and the cell culture bioreactors.

Thousand Oaks, Ca, Us

Manufacturing associate in cell culture facilities. Process lead for equipment maintenance.

Ph.D., Education And Human Resource Studies: Organizational Learning, Performance, And Change

Masters, Adult Education And Training

Bs: Microbiology, Genetic Engeineering