Director of Quality Control – QC

Director of Quality Control – QC Lead and manage the Pharmaceutical Quality Control Department in performing GMP physical and chemical testing of drug products, from raw materials, to in process and finished product. Establish strategic plan for QC, hire, train and supervise employees. Assure that QC Department meets regulatory requirements, US and worldwide, assist with documents for regulatory filings- IND, NDA, etc. Select and manage contract testing service companies. Coordinate with Quality Assurance, Regulatory Affairs, Manufacturing and others. Some travel is required.
REQUIREMENTS
Requirements: PhD in Analytical Chemistry or related with 10+ years or M.S. with 18 years of Pharmaceutical industry experience, including 4+ years of Quality Control management. Technical expertise should include strength in pharmaceutical drug analysis, USP testing, cGMPs, HPLC, GC, DMFs, FDA- NDA, and knowledge of methods development, validation, technology transfer. Very Good communications skills, technical knowledge, management/ leadership ability and ability to work well with others- company & suppliersare required.