Provide support,oversight, and management of regulated computerized systems to ensure full compliance with applicable GXP regulatory requirements, company policies, and procedures. This individual will be the primary QA presentative for computer...
Avalanche Biotech develops technologies and products for sustained delivery of therapeutic proteins to the eye to treat ophthalmologic disorders. The Manager, Clinical Quality Assurance will provide support, strategic oversight, and management of GLP...
Corium International, Inc.
Menlo Park ,
This position is primarily responsible for Quality Assurance activities to support R&D development projects - including clinical and preclinical studies. This position will mainly be focused in supporting cGMP activities and...
Intarcia Therapeutics, Inc.
The Sr. Manager, Quality Engineer candidate will be responsible for leading and managing the Design Control efforts for combination products and/or devices in accordance with FDA and other global regulations (21CFR4, 210/211, 820, IS0 13485, ICH Q9,...
Seattle Genetics, Inc.
The Seattle Genetics Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients. The Quality Assurance Manager is responsible for leading and coordinating the Commercial Manufacturing Quality...
Miltenyi Biotec, Inc.
Are you a quality assurance expert who would thrive in a GMP environment? Do you desire to step into a quality role where you can utilize your keen communication skills? If so, come and join our team as…
Senior Quality Assurance Associate -...
Radius Health, Inc. is seeking a Director, cGMP who has the ability to perform in a fast paced environment under tight deadlines and who has expertise in GMP/ISO verifications and validations of manufacturing process
FibroGen seeks a QA Director / Senior Director to be responsible for the QA function at FibroGen. This includes support for the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that FibroGen’s...
Central Admixture Pharmacy
Central Admixture Pharmacy Services, Inc.(CAPS), a company of B.Braun Medical Inc., is a state licensed pharmacy also operating as a manufacturer registered with the FDA. CAPS services originate from a free-standing facility with a focus to provide...
US Agent for Xellia to the Agency
? Maintenance of Xellia Drug Establishment Registrations (DER) covering all sites
? Drug Listing, Create NDC numbers
? Provide information on GDUFA requirements and GDUFA fees
? Major driver,...