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
• 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