Director, Product Development Quality

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

Job summary

Scorpion Therapeutics seeks a Development Quality leader to oversee quality for development-stage radiopharmaceutical programs, aligning with ICH, FDA, EMA, and USP requirements.

The role partners with cross-functional teams to implement fit-for-purpose GxP expectations, manage short half-life manufacturing quality topics, and prepare for regulatory interactions while leading a dedicated team.

Qualifications

• 10+ years progressive pharmaceutical/biotech/radiopharmaceutical quality experience with development-stage GMP depth.
• 7+ years leading/developing quality teams; experience building new quality functions.
• Direct experience with IND/CTA; NDA/BLA quality strategy; CTD Module 3 oversight/interaction with authorities.

Responsibilities

• Provide GMP quality oversight for development-stage radiopharmaceutical programs.
• Oversee short half-life manufacturing quality topics and related controls.
• Coordinate with Radiation Safety Officer on hot-cell qualification and dose calibrator validation.
• Lead Development Quality team; coaching, workload management and capability building.
• Represent Development Quality in stage-gates and governance forums; manage quality risk escalations.
• Support regulatory interactions/inspections as the Development Quality representative.

Skills

GMP quality oversight

Radiopharmaceutical quality

Quality leadership

Cross-functional collaboration

Regulatory agency interaction

IND/CTA regulatory submissions

Education

MS/PharmD/PhD in pharmacy/chemistry/radiochemistry

Bachelor's with equivalent experience

Job description

Responsibilities

• Provide GMP quality oversight for development-stage radiopharmaceutical programs, aligned with ICH, FDA, EMA, PMDA, USP, and relevant 10 CFR requirements.
• Partner with cross-functional teams to apply fit-for-purpose GxP expectations.
• Oversee short half-life manufacturing quality topics (e.g., RTRT, compressed release timelines, in-process controls).
• Coordinate with technical teams and the Radiation Safety Officer on hot-cell qualification, dose calibrator validation, and radiation safety quality interfaces.
• Provide Development Quality input/oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content.
• Support investigational medicinal product supply quality activities (CDMO oversight, comparator sourcing, packaging/labeling, distribution, and release).
• Review development documentation (manufacturing records, specifications, validation, deviations, CAPAs, change controls).
• Implement/continuously improve Development Quality procedures, templates, and governance; ensure scalability and alignment with enterprise Quality.
• Represent Development Quality in stage-gates and governance forums; manage quality risk escalation with internal/external partners.
• Support regulatory interactions/inspections as the Development Quality representative; prepare for inspection readiness.
• Lead and develop the Development Quality team (coaching, workload/performance, capability building).

Qualifications

• Advanced degree (MS, PharmD, PhD) in pharmacy/chemistry/radiochemistry or related field preferred; bachelor's with equivalent experience considered.
• 10+ years progressive pharmaceutical/biotech/radiopharmaceutical quality experience with development-stage GMP depth.
• 7+ years leading/developing quality teams; experience building new quality functions.
• Required: radiopharmaceutical quality experience (short half-life manufacturing, RTRT, USP compliance); oncology/targeted therapy preferred.
• Direct experience with IND/CTA; NDA/BLA quality strategy; CTD Module 3 authorship/oversight; regulatory agency interaction with FDA/EMA/PMDA required.

Key capabilities

• Results-oriented, strong communication/collaboration, resilience, inclusive mindset, adaptability, ethical behavior, continuous learning.