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.

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.

Quality Director – Manufacturing Expansion, Readiness

Key skills