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Job #03446

About our client Our client is a publicly traded pharmaceutical company headquartered in Michigan with over 10 years of success in the development and commercialization of nephrology and urology therapeutics. The company has an experienced management team, a world class scientific advisory board and a robust pipeline. This is a great situation for an executive that is interested in an opportunity to have a visible impact on a rapidly growing organization. Position Location Director of Quality Assurance/Regulatory Affairs Texas, Michigan or South Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Responsible for all company QA & QC activities; 3 manufacturing sites 2) Operation and maintenance of GMP documentation system 3) Qualification of vendors and contract manufacturers 4) Review of QC testing and lab procedures 5) Oversight of lab operations in a multi-site environment 6) Supplier and contract manufacturer auditing 7) Investigation of deviations and out of specification results 8) Review of process batch records and release of final product 9) Manage the change control process 10) Manage the stability testing program 11) Support of regulatory submission activities 12) Coordinate and handle regulatory affairs 13) Works with external consultants for regulatory submissions on new products 14) Lead and Direct timely validation of new facilities 15) Control of clinical trial material release and distribution Requirements 1) BS or MSc in biological or chemical sciences 2) 5-10 years prior experience in QA, regulatory experience a plus 3) Ability to operate independently and lead QA process 4) Operates to high GMP standards 5) Outstanding oral, interpersonal and written communication skills 6) Experience in food/nutrient processing or medical device environment preferred 7) Demonstrated ability to effectively interface with operations to correct process deficiencies