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Job #03480

About our client Our client is a mid-size pharma company focused on the development and commercialization of therapeutics that address unmet medical needs. They currently have one product on the market and one drug candidate that they have submitted to the FDA for market approval in addition to a robust pipeline. The company has strong financials, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees. Position Location Quality Assurance Manager Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Primary QA liaison with clinical/commercial manufacturing and testing facilities. 2) Assure compliance to current GMP regulations. 3) Responsible for review, approval and tracking of laboratory OOSs (inhouse and at CMOs) and manufacturing deviations and investigations. 4) Review of applicable analytical, equipment, systems, facilities, cleaning and process validation protocols and reports. 5) Responsible for review of manufacturing batch records. 6) Responsible for relevant stability programs including reviewing and approving stability protocols and reports, stability data, and preparation of stability documentation for regulatory submissions as required. 7) Responsible for coordinating and performing internal and external audits. 8) Prepare and review SOPs, specifications and other documents relevant to GMP operations. 9) Review of packaging records and oversight of packaging operations. 10) Review and approve protocols and reports for computer and database validation. Requirements 1) Minimum of a B.S. in Biology, Chemistry, Microbiology or related field. 2) Must have a minimum of 6 years of relevant experience within quality assurance and compliance in manufacturing environment. 3) Must have experience overseeing manufacturing operations (GMP compliance)in-house and at CMOs. 4) Must have previous biologics, drugs or biopharm experience. 5) Experience managing subordinates required.