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Job #03374

About our client Our client is a global pharmaceutical company headquartered in New Jersey. It is focused on the development and distribution of drug products for humans (chronic pain) and animals (anti-bionics, food additives). The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance Manager Chicago Heights, Illinois Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the quality assurance objectives in accordance to the company's global corporate policy and goals 2) Ensure cGMP compliance in all areas of the animal health facilities and laboratories 3) Oversee the company facility, laboratory, contract manufacturing and vendor audits with a resolution-based approach 4) Design and implement quality assurance training programs to all personnel 5) Maintain working knowledge of FDA, industry quality codes/standards and direct audits accordingly 6) Review and assist in the preparation of regulatory documents such as VMFs and NADAs 7) Supervise non-exempt and exempt personnel to achieve the above objectives 8) Oversee quality audits of all domestic and export facilities with a resolution-based approach to facilitate no inspectional observations 9) Review and approve documentation including, but not limited to manufacturing process and method validations, investigations, deviations and regulatory submissions 10) Manage complaints, adverse events, incident reporting and recall handling 11) Work with key personnel in the facilities on quality issues and resolution of discrepancies 12) Supervise and direct the workflow of quality associates 13) Maintain effective communications to report finding, assess needs and make recommendations to senior management 14) Support the Quality Management Team in personnel development, mentoring and coaching requiring strong interpersonal skills Requirements 1) BS or higher in Chemistry, Biology or in a related scientific field 2) CQA certification with Qumas experience preferred 3) Minimum 10 years of directly related QA experience in the pharma/biotech industry 4) Minimum 5 years of supervisory/leadership experience 5) Experience in leading FDA inspections and familiarity with FDA, CFR and USP guidelines 6) Good understanding of FDA, cGMP and GLP