Bachelors degree in Regulatory Affairs, Pharmaceutical Sciences, Computer and Information Technology, or a related field, or foreign degree equivalent; and 10 years of progressive, postbaccalaureate GMP or validation experience, including 7 years of experience in computerized system validation following industry standards GAMP, and cGMP; 5 years of experience interpreting and applying ICH guidance, regulatory guidance, and pharmaceutical organization guidance; 5 years of QA experience; and 7 years of experience working with change management systems. Experience may be gained concurrently.br br Employer will accept a Masters degree in Regulatory Affairs, Pharmaceutical Sciences, Computer and Information Technology, or a related field, or foreign degree equivalent; and 7 years of GMP or validation experience in lieu of a Bachelors degree and 10 years of the above experience. Any suitable combination of education, training, or experience is acceptable.br br Telecommuting from anywhere in the US is permitted

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