Jason Bissey Email Address

Senior Director of Quality Assurance

Xerimis is a privately held, specialized company providing customized clinical packaging services on a global basis.A Serving pharmaceutical, biotechnology and clinical research organizations of all sizes and for each phase of clinical development, Xerimis holds true to the traditional approach of building long-term relationships with clients.A Whether clients are currently working on an initial Phase I trial, or are in the midst of pivotal Phase III studies, we recognize that each trial is critical and we provide outstanding service and responsiveness to clients so that timelines are met or exceeded. Dedicated solely to clinical packaging, our level of involvement may range from a stand-alone service to complete management of all of your clinical supply needs.A In addition to providing clinical packaging and labeling services, we can assist with project management, protocol development, interpretation, comparator sourcing, procurement of ancillary supplies, and supply chain management as well as vendor management. Focused strictly on clinical packaging, our commitment to quality, reliability, service and responsiveness enables our clients to succeed and excel.

I first began work in the pharmaceutical industry in September of 2001 when I became a processing technician at Osteotech, Inc, located in Eatontown, NJ. In 2003 I was promoted to Senior Processing Technician, and was responsible for overseeing many of the daily processes in the Grafton® department. I was also extensively trained on the use of lyophilizers and was also training other employees in their correct use. I left Osteotech in 2004 and eventually began working at Xerimis, Inc. as a processing associate. I was promoted to Room Supervisor prior to being made permanent in December of 2004. I was trained in packaging and labeling, card sealing and bottle filling. In February of 2005 I was moved to the Quality Assurance group, where I began auditing completed Batch Record documentation, and I also began sending the completed Batch Records to clients for their review. As part of this process I was in contact with many clients both answering questions and providing insight into Xerimis procedures. In September of 2006 I was promoted to Senior Associate and was given responsibility of overseeing Batch Record pre-review as well as post-review. In March of 2007 I was promoted to Quality Assurance Manager and placed in charge of compliance. My position was responsible for assisting during client and vendor audits, performing Internal Audits, assisting with developing our Environmental Monitoring program, and assisting our Training Coordinator with our SOP program. In March of 2010 I was promoted to Director of Quality Assurance, following the departure of our Vice President of Quality Assurance, and I was given the responsibility of overseeing all of QA/QC, as well as leading client and vendor audits. Specialties: internal, client and vendor audits; managing personnel; writing and revising SOPs; GMP compliance; environmental monitoring