Quality Director – Manufacturing Expansion, Readiness

Job Description: • Develop and drive the end-to-end quality program for new radiopharmaceutical diagnostic and therapy manufacturing lines. • Ensure compliance with 21 CFR Parts 210, 211, and 212 as well as additional applicable standards for radiopharmaceuticals. • Lead cross-functional program governance, partner closely with functional support teams, and serve as the quality owner for major capital expansions and technology transfers. • Embed inspection readiness into all program phases; develop and integrate new lines into site Quality Systems. • Support risk assessments for equipment, utilities, materials, and processes. Requirements: • Bachelor’s or Master’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or related STEM field required. • 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with significant experience in capital projects or technical quality roles. Preference in radiopharmaceuticals required. • Strong background in GMP operations with expert understanding of 21 CFR Parts 210/211/212; additional experience with radiopharmaceuticals or sterile/aseptic manufacturing strongly preferred. • Demonstrated leadership in commissioning, qualification, validation (CQV), or tech transfer. • Deep expertise in quality engineering principles, risk management, and validation methodologies. • Experience with modern facility and equipment design for radiopharmaceutical or sterile operations (e.g., hot cells, isolators, shielded IVT lines). • Strong understanding of change control, deviation management, CAPA, and quality investigations. • Familiarity with FDA expectations for facility design, data integrity, and inspection readiness. Benefits: • Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development Apply Now Apply Now