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Job #03539

About our client Our client, a privately held pharmaceutical company, is focused on the development and commercialization of innovative therapeutics for the treatment of severe ocular diseases and conditions. Based in California, the company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the longterm professional development of it's employees. Position Location Quality Assurance Manager California Salary Highly competitive package, commensurate with experience Responsibilities The objective of this position is to independently execute Quality Assurance operations at the direction of the Director of QA. The objective of this position is also to provide expertise in quality guidance to resolve quality issues and ensure GMP operations are in compliance with company procedures, policies, quality standards, and FDA regulations. Primary Job Accountabilities: 1) Perform internal & external audits as necessary. 2) Supervise, manage and support the quality assurance personnel. 3) Involved in all new QA clinical activities and in all clinical QA related trouble shooting. 4) Responsible for the development of the Total Quality Management System. 5) Manages and maintains data bases for the quality system and prepares/assists in preparation of annual reports and quality trending reports. 6) Reports the status of the quality levels of staff, systems and production activities and participates in improvement programs. 7) Participates in the evaluation of quality events, incidents and possible complaints and the follow-up activities in the GMP departments. 8) Keep up to date with all related quality legislation and compliance issues. 9) Represent the company during external inspections. 10) Implement & oversee training program. 11) Review master & execute batch records as required. Requirements 1) BS degree in the chemistry or related field or equivalent preferred. 2) Min 5 years of experience in Quality Systems. 3) Min 2 years of lab experience. 4) Knowledge of FDA regulatory requirements. 5) Familiarity with medical and pharmaceutical industry, terminology and practices. 6) Proficient with MS Word, MS Project and Excel.