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Job #03197

About our client Our client is a publicly traded biopharmaceutical company that is dedicated to the development and commercialization of drug delivery therapies. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of it employees. This is a great opportunity for the right candidate. Position Location Quality Assurance Manager Miami, Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee Quality Assurance and cGMP compliance programs related to the manufacturing and packaging of transdermal as well as transoral pharmaceutical products 2) Supervise staff of on-line QA inspectors, samplers and component inspectors 3) Oversee and manage the activities of the quality assurance inspection area, (currently runs 2 shifts with the anticipation of a 3rd shift) 4) Monitor, mentor and supervise QA and inspection teams to ensure that quality issues are resolved as well as documented in a timely and efficient manner 5) Train departmental personnel to ensure compliance with regulatory guidelines, internal policies and SOPs 6) Monitor actual performance against established company and/or departmental goals, objectives and standards 7) Draft and revise departmental SOPs, forms and documents 8) Update procedures to reflect new or changed products, equipment, policies, FDA regulations and/or customer demands 9) Draft, review and approve deviations and investigations 10) Resolve and expedite product quality issues 11) Interface with customers, internal/external to address material or product quality and/or batch record issues 12) Participate in as well as recommend various QA activities and initiatives for improvement during meetings in support of departmental functions 13) Perform internal and external audits (as needed) 14) Compile, analyze, generate and publish (regularly) operational performance matrices 15) Participate (actively) in and/or support continuous-improvement initiatives Requirements 1) BS/BA in a scientific discipline 2) American Society for ASQ Certification a plus 3) Minimum 4 years of professional and supervisory experience in a FDA-regulated industry 4) Knowledge of cGMPs 5) Excellent problem-solving, technical writing and oral communication skills 6) Ability to work hands-on as well as in a team environment 7) Ability to interact with all levels of management in a professional and proactive manner 8) Excellent judgment skills 9) Highly organized with good attention to detail