Senior Manager, Development Quality
Telix Pharmaceuticals Limited
August 18, 2026
Remote friendly (United States)
United States
Operations
The Senior Manager, Development Quality serves as a senior technical and operational quality leader within Development Quality, overseeing CDMO/CMO quality activities and driving continuous improvement across development-stage radiopharmaceutical programs.
Key Accountabilities
- Lead GMP compliance oversight for radiopharmaceutical development programs manufactured by CDMOs/CMOs (real-time monitoring, batch disposition support, proactive compliance risk identification).
- Own preparation/review/approval of key QMS documents within Telix PQS; lead cross-functional process improvements.
- Provide senior guidance to manufacturing, project, and CMC teams on PQS requirements and quality expectations.
- Lead and independently execute investigational radiopharmaceutical batch release (review/approval of batch records, QC results, and COAs).
- Provide senior review/approval of SOPs, batch records, QC results, and regulatory documents; assess compliance gaps and escalate risk-based recommendations.
- Lead authoring/review/approval of deviations, investigations, CAPAs, and change controls; mentor junior staff.
- Provide day-to-day mentorship to junior team members; support onboarding/training.
- Lead quality oversight of CDMO/CMO relationships (supplier audits; manage observation closure; escalate systemic risks).
- Represent Development Quality in cross-functional governance and regulatory readiness activities.
Education & Experience / Qualifications
- BS/BSc+ in a science discipline (MS/PharmD preferred).
- 8+ years progressive quality experience in pharma/biotech/radiopharma with development-stage GMP and CDMO/CMO oversight.
- Direct radiopharmaceutical quality experience (short half-life manufacturing, USP, real-time release testing, hot-cell/dispensing QA).
- Expertise authoring/reviewing/approving SOPs, quality plans, technical quality documents; reviewing/approving batch records (radiopharma/sterile).
- Lead investigations, root cause analysis, CAPA management; independent approvals of complex deviations/change controls.
- Quality risk management using ICH Q9.
- Knowledge of 21 CFR 210/211/212, ICH (Q7/Q9/Q10), PIC/S GMP, USP; IND/CTA quality needs; CTD Module 3.
- Radiopharmaceutical industry experience required; PET or targeted radiotherapy preferred.
- Quality auditing experience (lead/co-lead GMP audits; observation closure preferred).
- Travel up to ~20%.
- Mentoring/technical oversight experience (people management a plus).
Key Accountabilities
- Lead GMP compliance oversight for radiopharmaceutical development programs manufactured by CDMOs/CMOs (real-time monitoring, batch disposition support, proactive compliance risk identification).
- Own preparation/review/approval of key QMS documents within Telix PQS; lead cross-functional process improvements.
- Provide senior guidance to manufacturing, project, and CMC teams on PQS requirements and quality expectations.
- Lead and independently execute investigational radiopharmaceutical batch release (review/approval of batch records, QC results, and COAs).
- Provide senior review/approval of SOPs, batch records, QC results, and regulatory documents; assess compliance gaps and escalate risk-based recommendations.
- Lead authoring/review/approval of deviations, investigations, CAPAs, and change controls; mentor junior staff.
- Provide day-to-day mentorship to junior team members; support onboarding/training.
- Lead quality oversight of CDMO/CMO relationships (supplier audits; manage observation closure; escalate systemic risks).
- Represent Development Quality in cross-functional governance and regulatory readiness activities.
Education & Experience / Qualifications
- BS/BSc+ in a science discipline (MS/PharmD preferred).
- 8+ years progressive quality experience in pharma/biotech/radiopharma with development-stage GMP and CDMO/CMO oversight.
- Direct radiopharmaceutical quality experience (short half-life manufacturing, USP, real-time release testing, hot-cell/dispensing QA).
- Expertise authoring/reviewing/approving SOPs, quality plans, technical quality documents; reviewing/approving batch records (radiopharma/sterile).
- Lead investigations, root cause analysis, CAPA management; independent approvals of complex deviations/change controls.
- Quality risk management using ICH Q9.
- Knowledge of 21 CFR 210/211/212, ICH (Q7/Q9/Q10), PIC/S GMP, USP; IND/CTA quality needs; CTD Module 3.
- Radiopharmaceutical industry experience required; PET or targeted radiotherapy preferred.
- Quality auditing experience (lead/co-lead GMP audits; observation closure preferred).
- Travel up to ~20%.
- Mentoring/technical oversight experience (people management a plus).