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Job #02437

About our client Our client is a publicly traded pharmaceutical company headquartered in New York that is dedicated to the development and commercialization of specialty generic and proprietary therapeutics. The company has strong financials, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Associate Director Clinical Quality Assurance Northeastern New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist head of CQA in oversight of the quality system and CQA program 2) Assess accuracy and quality of data and ensure GCP compliance 3) Conduct and supervise audits of internal processes/procedures, investigators, databases, reports, contract CROs/Labs/IRBs 4) Assist in management of CQA associates/contractors and CROs 5) Train and mentor junior auditors 6) Investigate and resolve compliance problems 7) Work with functional areas to create and maintain SOPs for CQA 8) Provide CQA support for regulatory filings Requirements 1) Bachelor’s degree (advanced degree preferred) 2) 5+ years of pharmaceutical clinical quality experience 3) 5+ years of clinical quality experience 4) 2+ years of supervisory experience 5) Experience in auditing CROs/Labs/IRBs/Study Reports 6) Strong knowledge of FDA, ICH and other regulations, GCPs and audit procedures 7) Ability to write effective SOPs, training materials and CQA reports 8) Exceptional communication, planning and problem-solving skills 9) Willingness to travel – up to 40% (domestic and international)