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Job #03629

About our client Our client is a mid-size pharmaceutical company with a robust pipeline and a number of products in late-stage clinical trials. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Director of Quality Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop short- and long-term goals and procedures that meet the organization's quality objectives and are consistent with FDA cGMP compliance 2) Coordinate and recommend improvement initiatives and quality policy 3) Develop and manage a quality improvement plan 4) Interface with FDA and other regulatory agencies to coordinate inspections and investigate complaints 5) Develop, implement and direct the company's internal and external quality system audits including investigations/deviations, Out-of-Specification (OOS) and CAPA reporting 6) Direct the development, improvement, validation and troubleshooting for QC analytical testing and raw material release, batch release and environmental monitoring 7) Develop and direct validation programs (IQ/OQ/PQ) to ensure compliance with cGMP 8) Oversee, develop and maintain validation documentation (e.g., master plans, protocols, change controls, summary reports, etc.) 9) Direct the development of systems for measuring compliance with the company’s quality goals, objectives and standards and recommend corrective action as required 10) Help develop training for employees in quality improvement principles and corporate compliance requirements 11) Ensure personnel meet cGMP training requirements 12) Provide approval authority of all procedures, variance reports and compliance activities 13) Audit and approve vendors based on quality-related issues 14) Implement and manage procedures for batch record review and product release 15) Review and approve all relevant policies and procedures 16) Ensure inspection readiness 17) Handle QC laboratory and materials management, oversee quality and other duties including designing, developing and implementing QC laboratory and material management functionality, etc. 18) Remain current in and advise the organization on the evolving regulatory environment that surrounds the business 19) Ensure that laboratory staff is properly trained on SOPs 20) Approve the investigations of all OOS results, stability failures and lab-related deviations Requirements 1) BS in Science 2) Minimum 5 years of working experience in QA/QC in a development/ manufacturing environment within the biotechnology/pharmaceutical drug industry 3) Additional advanced training in areas of pharmaceutical industry-related practices, 21 CFR Part II and GMP helpful 4) Experience in auditing, creating SOP and reviewing critical documents 5) Experience in current GMPs, vendor audits, FDA regulations, quality system regulations and team development 6) Broad regulatory, cGMP/SOP, background in auditing and managing validation efforts and writing protocols