Quality Director, Manufacturing Compliance

Job Summary

A company is looking for a Quality Director, Manufacturing Expansion & Readiness.

Key Responsibilities

• Lead the Quality Program for new radiopharmaceutical diagnostic and therapy line buildouts and expansions
• Ensure compliance with GMP standards and oversee quality input into design and validation processes
• Embed inspection readiness into all program phases and integrate new lines into site Quality Systems

Required Qualifications

• Bachelor's or Master's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related STEM field
• 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with a focus on capital projects or technical quality roles
• Strong background in GMP operations and expert understanding of 21 CFR Parts 210/211/212
• Demonstrated leadership in commissioning, qualification, and validation (CQV) or tech transfer
• Experience with modern facility and equipment design for radiopharmaceutical or sterile operations