Senior Manager, Development Quality

Role: Senior Manager, Development Quality at Telix Pharmaceuticals, overseeing quality activities for radiopharmaceutical development programs, including GMP compliance, batch release, and quality system processes. Responsibilities: lead GMP oversight for manufacturing with CDMOs/CMOs, manage deviation, CAPA, and change control processes, review and approve batch records and regulatory documents, and provide guidance on radiopharmaceutical GMP requirements. Act as primary quality interface with external manufacturing partners, conduct or oversee vendor audits, and mentor junior team members. Contribute to building scalable quality processes supporting IND-stage programs across multiple jurisdictions. Qualifications: BS in a science-related field; 8+ years’ experience in pharmaceutical or radiopharmaceutical quality, with expertise in GMP, sterile or radiopharmaceutical manufacturing, and regulatory compliance (21 CFR, USP, ICH). Demonstrated ability to lead investigations, author technical quality documents, and manage vendor quality oversight. Preferred: advanced degree (MS, PharmD), radiopharmaceutical industry experience, and GMP audit experience. HighValue: radiopharmaceutical GMP, IND-stage development, short half-life manufacturing, PET diagnostics or radiotherapy, cross-functional collaboration, and international vendor management. Work setup: hybrid/remote with up to 20% travel for audits and site visits.