Director of Quality Systems & Compliance

Wave Life Sciences; Lexington (MA); On-site; USD 193,000 - 261,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid time off

401(k) with matching

Employee Stock Purchase Program

Job summary

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes and ensure GMP/GXP readiness as Wave progresses toward commercialization. This is an onsite role with four days/week presence at our Lexington facility.

The position requires 10–12 years in QA within the pharmaceutical industry, with 5 years in people management, and hands-on experience implementing QMS, documentation systems, and LMS. Strong collaboration and regulatory knowledge are essential.

Qualifications

• BS in a scientific discipline.
• 10–12 years’ QA experience in pharma with 5+ years managing personnel.
• Experience implementing enterprise QMS, documentation systems and LMS.
• Minimum 3 years in Vendor Qualification/Management.
• Ability to influence, coach others, and lead teams.
• Strong regulatory knowledge (FDA/EMA) and problem-solving skills.

Responsibilities

• Improve and streamline QMS processes: Change Control, Deviations, CAPA, Document Management, GxP Training, and Vendor Management.
• Assess current Quality Systems and plan for inspection readiness.
• Develop QS team with a culture of collaboration and continuous improvement.
• Oversee QS policies, procedures, and templates.
• Ensure compliance with FDA/EMA/ICH and other global regulations.
• Establish eQMS performance metrics for effectiveness and compliance.
• Lead cross-functional process improvements and align QS with business operations.

Skills

B.S. in life science

Quality Assurance

Vendor Qualification

GXP / cGMP

QMS/eQMS implementation

Team leadership

Regulatory knowledge (FDA/EMA)

Cross-functional collaboration

CSV/electronic systems

Audits & inspections

Education

Bachelor's degree in a scientific discipline

Tools

Quality Management System (QMS)

Documentation System

Learning Management System (LMS)

Veeva

CSV principles

eQMS

Job description

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes and ensure GMP/GXP readiness as Wave progresses toward commercialization. This is an onsite role with four days/week presence at our Lexington facility.

The position requires 10–12 years in QA within the pharmaceutical industry, with 5 years in people management, and hands-on experience implementing QMS, documentation systems, and LMS. Strong collaboration and regulatory knowledge are essential.