Job Details

A company is looking for a Quality Director, Manufacturing Expansion & Readiness.Key ResponsibilitiesLead the Quality Program for new radiopharmaceutical diagnostic and therapy line buildouts and expansionsEnsure compliance with GMP standards and oversee quality input into design and validation processesEmbed inspection readiness into all program phases and integrate new lines into site Quality SystemsRequired QualificationsBachelor's or Master's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related STEM field10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with a focus on capital projects or technical quality rolesStrong background in GMP operations and expert understanding of 21 CFR Parts 210/211/212Demonstrated leadership in commissioning, qualification, and validation (CQV) or tech transferExperience with modern facility and equipment design for radiopharmaceutical or sterile operations