The Manager, Quality ensures GMP and Regulatory Compliance of the CMO portfolio of products for Dechra in the US. The Manager, Quality maintains Quality oversight of the Metro Park Warehouse and supports all Quality related issues at Dechra US sites.
The position is located in either Overland Park, Kansas or Portland, Maine.
The successful candidate has 2 or more years of Quality management experience as well as GMP and GDP audit experience. He or she has experience hosting FDA/EU regulatory inspections and has worked with different dosage forms including topical liquids, oral solid and liquid doses and sterile injectibles. The successful candidate also brings a demonstrated understanding of US and global compliance and regulatory requirements for regulated pharmaceutical products and non-regulated health consumer products as well as demonstrated problem solving skills and the ability to pragmatically apply a risk based approach in resolving product/process/analytical related issues. The ideal candidate has experience in one or more of the following areas: analytical chemistry, formulation development, microbiology, manufacturing, packaging and labeling, ISO inspections, product development and generic drugs.