IRONWOOD PHARMACEUTICALS INC. – $121,555.00/Year

H. 10B. cont.; or in the alternative, a Masters degree or equivalent and three years of work experience. Specific skills If qualifying with a Bachelors degree, must have the following Five years of experience working in a cGMPGXP environment; Three years of experience as a Quality System Software administrator; Five years of experience with applicable regulations and guidance, such as Food and Drug Administration FDA guidelines 21 CFR parts 11, 210, 211, 800, 820; Data Integrity and Compliance with Drug CGMP Guidance for Industry; FDA General Principles of Software Validation; FDA Guidance Document Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; ICH Q8, Q9, and Q10; and Three years of experience with practical application of riskbased approach to quality system principles and regulatory compliance within the pharmaceutical industry. If qualifying with a Master s degree, must have the following Three years of experience working in a cGMPGXP environment; One year of experience as a Quality System Software administrator; Three years of experience with applicable regulations and guidance, such as Food and Drug Administration FDA guidelines 21 CFR parts 11, 210, 211, 800, 820; Data Integrity and Compliance with Drug CGMP Guidance for Industry; FDA General Principles of Software Validation; FDA Guidance Document Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; ICH Q8, Q9, and Q10; and Two years of experience with practical application of riskbased approach to quality system principles and regulatory compliance within the pharmaceutical industry. Ironwood has adopted a hybrid work environment where employees have the option to work from home within normal commuting distance from the office location. Vaccination and testing required for inoffice work.