Sr. Director, RA/QA Strategy & Business Integration

Foundation Medicine; United States; On-site; USD 180,000 - 270,000; Full time

Job summary

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.

Responsibilities

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

Skills

Cross-functional governance

Regulatory strategy

Stakeholder engagement

Leadership in matrixed orgs

Education

Bachelor's degree in Life Sciences/Engineering

Job description

Role: Senior Director, RA/QA Strategy & Business Integration, serving as the primary interface between Regulatory Affairs/Quality Assurance and internal cross-functional teams (Product, R&D, Operations) as well as external partners. Objectives include shaping regulatory and product strategies, integrating RA/QA early into development, and positioning RA/QA as a strategic driver of innovation and competitive advantage.

Responsibilities

• leading cross-functional governance
• guiding development pathways for biotech/diagnostics products
• representing FMI externally to influence industry standards

Qualifications

• Bachelor’s 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.

Preferred

• Advanced degrees (PhD, MS, MBA), expertise in diagnostics, IVD, or precision medicine, and experience in global regulatory landscapes.

High-Value

• Focus on diagnostics/IVD, regulated product lifecycle support, external engagement, and strategic leadership.

Work setup

• Remote, with expectations for external representation and stakeholder collaboration.