Director, Quality Systems — GMP/QA Leader (Onsite)

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

Job summary

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes and the eQMS at our Lexington facility. This onsite role focuses on GMP/GxP areas with a strong emphasis on continuous improvement, training, and vendor management.

Four days/week onsite is required, with strategic leadership across QA and regulatory functions. The role requires a BS in a science, 10–12 years in QA within pharma, and deep experience implementing QMS, CV/CSV systems, and vendor

Qualifications

• BS in a scientific discipline.
• 10–12 years QA experience in the pharmaceutical industry with 5 years of people management.
• Significant expertise with QMS, Documentation and Learning Management systems.
• Minimum 3 years’ experience with Vendor Qualification and Management.
• Ability to influence peers, coach others, and lead teams to meet timelines.

Responsibilities

• Improve and streamline QMS processes such as Change Control, Deviations, CAPA, Documentation, Training and Vendor Management.
• Develop a staged plan to achieve inspection readiness and build a QS team culture.
• Oversee development, maintenance, and optimization of QS policies, procedures and templates.
• Ensure QS processes comply with global regulatory requirements (FDA, EMA, ICH).
• Establish and monitor eQMS performance metrics and drive cross-functional improvements.
• Lead audits and regulatory inspection preparation and responses.

Skills

QA leadership

GXP knowledge

Vendor management

eQMS systems

Documentation management

Regulatory liaison

CSV experience

Cross-functional collaboration

Education

BS in scientific discipline

Tools

Veeva experience

QMS software

Job description

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes and the eQMS at our Lexington facility. This onsite role focuses on GMP/GxP areas with a strong emphasis on continuous improvement, training, and vendor management.

Four days/week onsite is required, with strategic leadership across QA and regulatory functions. The role requires a BS in a science, 10–12 years in QA within pharma, and deep experience implementing QMS, CV/CSV systems, and vendor