Associate Director QA

Associate Director, Quality Assurance (Clinical and Pre-Clinical) This opportunity is with a pharmaceutical company.  The Associate Director, QA is responsible for all key QA functions within the scope of pre-clinical and clinical research.  The individual in this position will be responsible for qualifying and auditing of contract laboratories, contract research organizations and manufacturing facilities to ensure compliance with GLP, GCP and GMP guidelines.  The Associate Director, QA will review IND and NDA sections prior to regulatory submissions, review SOPs, recommend corrective actions and provide QA input on product development issues.  Qualified candidates will have at least a BS in Life Sciences or similar scientific discipline, as well as a minimum of 6 years in the pharmaceutical industry.  Experience must include the performance of internal and external audits to assess regulatory and procedural compliance.  Candidates must be knowledgeable of GLP, GCP and GMP regulations and guidelines stemming from FDA, OECD and ICH.  Candidates must have excellent communication skills and enjoy working in a team environment.  Experience with electronic document control systems a plus.