Develop and drive the end-to-end quality program for new manufacturing lines.
Ensure compliance with 21 CFR Parts 210, 211, 212 and additional standards.
Lead cross functional program governance and partner with Engineering, Operations, Validation, Regulatory Affairs, and Quality Control.
Ensure new lines are designed and implemented with a “Safety & Quality Always” mindset.

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