Associate Director- Clinical Quality Assurance (Specialty Pharma)

Our client, a specialty pharmaceutical company with headquarters in Research Triangle Park, NC, is actively recruiting for a highly competent, seasoned and versatile Quality leader for key role driving all Clinical Quality Assurance efforts – including clinical research and clinical materials and supplies.  Company has multiple products on the market and many more in the pipeline.  Extensive growth is underway and more is projected.  Seek smart, knowledgeable and accomplished leader to drive this important Quality Assurance function.

Ideal candidate will offer:

Ø  extensive experience in clinical vendor selection, audits and reviews as well as savvy ability to establish systems, processes and procedures in a growing environment in which old operating plans no longer meet future needs. 

Ø  expert knowledge of GCP principles and practices. 

Ø  background in CRO leadership and clinical research management desirable (if complemented by 3+ years in clinical quality assurance). 

Ø  deep and broad knowledge of CQA requirements, guidelines, and strategies, complemented by reliable and effective project/operations management skills 

Ø  the ability/desire to add value in a highly entrepreneurial & empowered setting. 

Finally, Clinical Research is largely handled through CROs.  Production is outsourced to contract manufacturers.  Successful candidate must offer proven ability to drive quality functions in an outsourced setting.

This is a critical role and finding the right person is a top priority.  Company is prepared to pay top dollar (generous base, bonus, benefits, stock, etc) for their ideal person and will relocate top-notch candidate. 

Please forward Word resume.