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Job #02979

About our client Our client is an expanding development-stage biopharmaceutical company with cutting-edge technology in the area of large molecule delivery systems. With an experienced management team and an established set of large pharma partners, this is a high visibility position that will expose the right candidate to some of the most intriguing programs in the Life Sciences sector. Position Location Senior Manager, Quality Assurance New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Audit and approve control processes, procedures and documentation 2) Conduct cGMP facility audits 3) Review batch records 4) Conduct CRO, contact manufacturing and vendor facility inspections 5) Appraise Stability Protocol, reports and data 6) Review protocols, method validations and equipment qualification records 7) Assess approval of deviations and out-of-specifications data (OOS) as well as reports 8) Coordinate and implement corporate quality audit policies with emphasis on changes related to FDA current cGMPs, GLPs and GCPs 9) Review and maintain all the protocols and amendments as per GLP regulations 10) Generate and circulate written audit reports to the Study Director and management 11) Draft final study reports and issue a quality assurance statement 12) Maintain master schedule 13) Conduct or coordinate FDA or other government agencies’ inspections 14) Host partner audits 15) Audit clinical and non-clinical CROs, data management and analytical sites 16) Perform room clearance for the manufacturing processes 17) Evaluate the company's SOPs 18) Review analysis reports and the certificate of analysis 19) Appraise label’s text for the clinical trials materials 20) Review cleaning assessment programs for clinical trial materials 21) Maintain timelines for environmental monitoring in GMP areas Requirements 1) BS with minimum 10 years of experience in documentation control (or MS with minimum 3 years of experience in pharmaceutical manufacturing, clinical and non-clinical development) 2) Working knowledge of FDA GXP regulations and guidelines 3) Trained in auditing techniques and compliance auditing 4) FDA audit experience 5) Supplier (CRO) audit experience