Senior Manager, Development Quality

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Manager, Development Quality to lead GMP compliance and drive continuous improvement across radiopharmaceutical development programs. You will oversee CDMO/CMO quality activities, author QC/QA documentation, and mentor junior staff within a fast-paced, regulated environment.

The role requires 8+ years of pharma quality experience, radiopharmaceutical expertise, and strong cross-functional collaboration to ensure regulatory readiness and successful batch

Qualifications

• 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.
• Travel up to ~20%.

Responsibilities

• 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 elevate 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; elevate systemic risks).
• Represent Development Quality in cross-functional governance and regulatory readiness activities.

Skills

Quality leadership

Regulatory compliance

GMP knowledge

Cross-functional leadership

Education

BS/BSc in science discipline (MS/PharmD preferred)

Job description

Senior Manager, Development Quality

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 elevate 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; elevate 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).