Alan Rich, MBA

External Consultant

Alan is a proven quality professional with consistent success in the development, establishment and maintenance of FDA regulated Quality Systems within dynamic and cutting-edge industries. Passionate about a Quality System’s ability to exceed both internal and external customer and business requirements, he is a strategic thinker who combines visionary ideas with demonstrable results in both national and international markets.

More about Alan

Alan has over forty years of experience in quality systems and management. He utilizes proven and innovative techniques in complying with QSR (21 CFR 820, 210, 211), CE IVD and ISO requirements. He prides himself on being a tactical problem solver with a keen sense for helping developmental teams to “do it right the first time”. Alan is steadfastly focused on building quality into the design process, procedures, and processes within all levels of an organization.

Alan supports the Sanova team by providing experienced leadership in developing quality management systems from the ground up in a wide varietry of FDA regulated industries to auditing and conducting gap analysis and remediation services.

Education

Alan earned his MBA at Pepperdine University in Malibu, California and his BS in Medical Technology (minor in Chemistry) at Brigham Young University, Provo, Utah

Representative Work Experience

2014 - present

2009 - 2014

Silgan Dispensing Unicep Packaging (www.silganunicep.com). Alan worked in a number of capacities both for Unicep and then for Silgan Unicep from Directory of Quality and Regulatory Affairs to Global Quality Assurance Auditor. In these roles, Alan was responsible for providing leadership in quality management systems for multi-sites within a global products division developing and manufacturing specialized liquid and gel products for the device, drug, food, cosmetic, animal health and industrial markets.

Meridian Life Science, Inc. Meridian provides antibodies, viral antigens, recombinant proteins, contract biologic (Phase 1 and 2 Clinical Trial vaccines), R&D and manufacturing services in the diagnostic and biopharmaceutical markets. Alan served as Director of Regulatory Affairs, QA/QC responsible for all activities within the Regulatory Affairs, Quality Assurance, Quality Control, Metrology and Validation departments, ensuring compliance with cGMP regulations.

2006 - 2009

Asuragen, Inc. While at Asuragen, a. privately held start-up biotechnology company focused on oncology, genetic screening and customer testing services, Alan held the role of Associate Director, QA responsible for DHR, DMR and Technical files, document control, training, risk management, CAPA and customer complaint management in order ot maintain compliance with cGMP/GLP/GCP standards.