Associate Director/Director QA

This will be a highly sought after role once released as this company is extremely stable financially and looking to expand. The Associate Director/Director, QA will develop, implement, and maintain GMP Quality Systems as well as oversee domestic and European CMOs in accordance to GMP requirements. Job Responsibilities: * Assure cGMP requirements and company quality standards are recognized and understood at the CMOs and maintained internally. * Provide quality oversight at contract manufacturing organizations (CMOs) located in US and Europe. * Assist with vendor management through participation in compliance audits. * Review and approve batch documentation, product specifications, change control requests, and analytical data. * Interact with interdepartmental contacts on resolution, discrepancy assessment, and Quality approval. * Ensure finished products and processes conform to company policies and procedures as well as other applicable US, FDA, EMA and ICH regulations and guidelines. * Develop improvements to quality systems and processes * Lead operational planning for the Product Release group and ensures tactical objectives are met in support of strategic targets. Qualifications: * B.A. or B.S degree in relevant scientific discipline. * Quality professional with 10+ years of hands on experience with increasing responsibility in a QA function in the pharmaceutical, biotechnology or related industry * Significant hands on experience with small molecules. 5+ years of batch review and disposition. * Must be capable of applying cGMP concepts and requirements to evaluate product disposition and using sound judgment and decision-making skills. * Experience with implementing quality systems in a GMP environment. * Extensive knowledge of cGMPs and US/EMA/ICH regulations and guidances. This is an exciting position and a great career move for the right candidate. For more information and to apply for an interview, please respond to b.ross(@)realstaffing.com

To find out more about Real please visit www.realstaffing.com [1]

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