Director, Quality Systems - GMP & Regulatory Readiness

Scorpion Therapeutics; Lexington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Wave Life Sciences is seeking a Director of Quality Systems to lead GXP foundational processes from development to commercialization, including document control, vendor qualification, and eQMS oversight.

You will drive inspection readiness, policy development, and audits, building cross-functional partnerships while ensuring regulatory compliance with FDA, EMA, and ICH standards in a biotech context focused on RNA-based therapies.

Qualifications

• BS in a scientific discipline; 10-12 years in QA within pharma.
• Minimum 5 years of people management experience.
• Extensive experience with enterprise quality systems and regulatory compliance (FDA/EMA/ICH).

Responsibilities

• Improve and streamline QMS processes; develop inspection readiness.
• Lead cross-functional initiatives and policy development.
• Oversee audit preparations (internal and external).

Skills

Leadership

Cross-functional collaboration

Communication

Regulatory knowledge (FDA/EMA/ICH)

Education

BS in a scientific discipline

Tools

Veeva

Enterprise Quality Systems

Vendor qualification

Job description

Wave Life Sciences is seeking a Director of Quality Systems to lead GXP foundational processes from development to commercialization, including document control, vendor qualification, and eQMS oversight.

You will drive inspection readiness, policy development, and audits, building cross-functional partnerships while ensuring regulatory compliance with FDA, EMA, and ICH standards in a biotech context focused on RNA-based therapies.