Remote Senior Director, RA/QA Strategy & Integration

Foundation Medicine; United States; À distance; USD 180 000 - 270 000; Plein temps

Résumé du poste

Scorpion Therapeutics seeks a Senior Director of RA/QA Strategy & Business Integration to align Regulatory Affairs and Quality Assurance with product, R&D and operations. You will drive strategic regulatory initiatives, integrate RA/QA into development early, and position RA/QA as a driver of innovation and competitive advantage.

The role requires leading cross-functional governance, guiding development pathways for biotech/diagnostics products, and representing FMI externally to influence

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 12+ years in QA/RA within biotech, diagnostics, or medical devices.
• Extensive experience in regulatory strategy supporting product development in regulated environments (FDA, CLIA, IVDR).
• 5+ years of leadership in matrixed organizations with influencing and stakeholder engagement skills.

Responsabilités

• Lead cross-functional governance across RA/QA and other functions.
• Guide development pathways for biotech/diagnostics products.
• Represent FMI externally to influence industry standards.

Connaissances

Cross-functional governance

Regulatory strategy

Stakeholder engagement

Leadership in matrixed orgs

Formation

Bachelor's degree in Life Sciences/Engineering

Description du poste

Scorpion Therapeutics seeks a Senior Director of RA/QA Strategy & Business Integration to align Regulatory Affairs and Quality Assurance with product, R&D and operations. You will drive strategic regulatory initiatives, integrate RA/QA into development early, and position RA/QA as a driver of innovation and competitive advantage.

The role requires leading cross-functional governance, guiding development pathways for biotech/diagnostics products, and representing FMI externally to influence