Director, Quality Systems

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

Role

Director of Quality Systems at Wave Life Sciences, overseeing GXP foundational processes including document control, vendor management, and eQMS to ensure compliance from investigational stages to commercialization.

Responsibilities

improve and streamline QMS processes, develop inspection readiness, lead cross-functional initiatives, oversee policy development, and manage internal/external audit preparations.

Requirements

BS in a scientific discipline, 10-12 years in QA within the pharmaceutical industry, with at least 5 years managing personnel; extensive experience with enterprise quality systems, vendor qualification, and regulatory compliance (FDA, EMA, ICH); strong leadership, collaboration, and communication skills.

Preferred

experience with CSV principles, Veeva, combination products, and GMP support in the biotech/pharma context.

HighValue

focus on GMP compliance, quality process improvement, and regulatory readiness in a biotech setting supporting RNA-based therapies and clinical programs.

Work setup

onsite in Lexington, 4 days/week.