Director, Product Development Quality

Role: Director of Product Development Quality leading quality assurance for radiopharmaceutical development from early clinical stages to registration-readiness. Responsibilities: oversee GMP compliance specific to radiopharmaceuticals, support IND/CTA submissions, ensure quality oversight of clinical supply chain and manufacturing partners, develop and improve quality systems, and represent quality in regulatory interactions and inspections. Lead and grow a high-performing development quality team, ensuring documentation, risk management, and cross-functional collaboration align with global GMP standards. Qualifications: advanced degree (MS, PharmD, PhD) in relevant scientific discipline; 10+ years’ progressive quality experience in pharma/biotech/radiopharma, with 7+ years leading quality teams; direct radiopharmaceutical GMP expertise, familiarity with short half-life manufacturing, real-time release testing, and USP compliance. Demonstrated experience with IND/CTA submissions and regulatory agency interactions (FDA, EMA, PMDA). High-Value: radiopharmaceuticals, GMP compliance, development-stage quality, oncology/targeted therapies, regulatory submissions, cross-functional oversight, global regulatory environment. Work setup: hybrid/remote, with international stakeholder engagement.