Site Quality Director
Core
Provide site leadership and oversight for QA, QC, and compliance activities to ensure the supply of high-quality radio conjugate products and maintain cGMP compliance.
Role type
Senior IC Site Quality Director (Radiopharmaceuticals)
Builds
Radio conjugate quality products for oncology markets
Domain
Life Sciences / Radiopharmaceuticals / Oncology
Required skills
cGMP compliance, regulatory inspection readiness, CAPA management, resource planning, budget management, lean design, team coaching, aseptic manufacturing knowledge, FDA/ICH/EU GMP regulations
Preferred skills
Radio conjugates experience, advanced degree, international matrix organization experience
Technologies
GMP systems, batch record review tools, qualification protocols
Responsibilities
Ensure finished products meet cGMP and regulatory commitments; Set site quality goals aligned with global objectives; Track and report quality metrics; Prevent non-compliance issues; Manage site budget and organizational development; Lead continuous improvement initiatives; Coach and develop direct reports; Ensure timely testing and release of materials; Maintain 24/7 inspection readiness.
Seniority
Senior, hands-on IC with leadership responsibilities
