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Job #02856

About our client Our client is a reputable pharmaceutical company that is focused on the development and commercialization of various veterinary therapeutics. 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 Iowa Salary Highly competitive package, commensurate with experience Responsibilities 1) Understand and interpret GCP mandates 2) Learn and understand relevant regulations mandated by federal, state, local and foreign agencies that affect the company 3) Advise senior management on applicable regulations 4) Review and/or develop protocols for conducting tests or validation techniques necessary for approval of facilities or products (especially the ones mandated by the FDA or USDA) 5) Plan and execute Quality Assurance strategies and procedures to ensure compliance with regulatory requirements 6) Define and direct corporate quality policies, qualifications and validations 7) Develop, direct, monitor, evaluate, document and communicate quality assurance program 8) Respond (in a timely manner) to inspection reports, such as FDA Form 483 9) Investigate customer complaints 10) Work on special projects (as assigned) 11) Maintain work areas in a neat and orderly way Requirements 1) BS with relevant experience in pharmaceutical manufacturing 2) 5 years of experience in pharmaceutical solid dosage manufacturing and quality operations with 3 years in personnel supervision and management 3) Ability to comprehend written regulations for development, manufacturing and distribution of drug policies 4) Experience in drug manufacturing and solid dosage or injectables 5) Thorough knowledge of cGMP, USP and International Conference on Harmonization (ICH) 6) Good understanding of the technical, regulatory and commercial aspects of pharmaceutical products 7) Previous experience in interacting with regulatory agencies (i.e. FDA) and other internal/external auditing groups 8) Proven ability to interface effectively with senior management, auditors and regulators 9) Ability to use good judgmental skills in investigation problems 10) Ability and skills to maintain a cooperative working relationship with other personnel 11) Aptitude for recognizing and dealing with priorities 12) Previous experience in statistical analysis, raw materials laboratory and chemical testing/manufacturing 13) Ability to perform internal/external audits