Director, Quality Systems

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Wave Life Sciences is seeking a leader to head the internal Quality Systems team, focusing on GXP and GMP foundational processes such as document control, vendor qualification, and electronic Quality Management Systems (eQMS) to ensure compliance and readiness for inspections.

You will drive cross-functional collaboration, build a high-performing QS team, and oversee regulatory compliance with FDA, EMA, and ICH.

Qualifications

• BS in a scientific discipline.
• 10–12+ years in pharmaceutical QA.
• 5+ years managing personnel.
• Extensive experience with enterprise quality systems.
• Vendor qualification and GxP principles.

Responsibilities

• Lead internal Quality Systems team focusing on GXP and GMP foundational processes.
• Oversee document control, vendor management, and eQMS.
• Maintain regulatory compliance with FDA, EMA, and ICH.
• Drive cross-functional collaboration for quality initiatives and inspections readiness.

Skills

Leadership

Communication

Change management

GxP principles

Education

BS in a scientific discipline

Tools

Veeva

CSV

eQMS

Job description

Role: Lead the internal Quality Systems team at Wave Life Sciences, focusing on GXP and GMP foundational processes such as document control, vendor management, and electronic Quality Management Systems (eQMS). Primary objectives include ensuring compliance, process improvement, and readiness for regulatory inspections as the company advances from investigational to commercial stages. Responsibilities encompass optimizing QMS processes, developing a high-performing QS team, maintaining regulatory compliance (FDA, EMA, ICH), and facilitating cross-functional collaborations for quality initiatives. The role involves strategic planning, process optimization, audit readiness, and fostering a culture of continuous improvement within a fast-paced biopharma environment.

Requirements

• BS in a scientific discipline, 10-12+ years in pharmaceutical QA, 5+ years managing personnel, extensive experience with enterprise quality systems, vendor qualification, and GxP principles
• strong leadership, communication, and change management skills.

Preferred

• Veeva experience, CSV and electronic system expertise, and familiarity with combination product regulations.

High-Value

• GMP and GXP focus, global regulatory compliance, Quality System development, and onsite presence at Lexington facility (4 days/week).