GMP-Driven Quality Systems Director

Regulatory Jobs; Lexington (MA); On-site; USD 193,000 - 261,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Comprehensive benefits package

Job summary

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes, including GxP training, document control, vendor management, and the eQMS. This onsite role requires four days per week at the Lexington, MA facility to support GMP-focused activities and broader GXP work as Wave moves toward commercialization.

The role demands a BS in a scientific discipline, 10–12 years in QA in pharma with 5+ years managing staff, and deep experience implementing and improving

Qualifications

• BS in a scientific discipline.
• Minimum 10-12 years’ experience in Quality Assurance in the pharmaceutical industry and 5 years managing personnel.
• Significant expertise with enterprise systems: Quality Management Systems, Documentation Systems, and Learning Management Systems.
• Minimum 3 years’ experience with Vendor Qualification and Management.
• Ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues.
• Knowledge of cGMP principles with respect to US, EU, and other regulatory guidance.

Responsibilities

• Improve and streamline QMS processes (Change Control, Deviations, CAPA, Document Management, GxP Training, Vendor Management).
• Assess current state of Quality Systems and develop a plan to achieve inspection readiness.
• Build and lead QS team with a culture of continuous improvement and customer service.
• Maintain and optimize QS policies, procedures, and templates.
• Ensure QS processes comply with global regulatory requirements (FDA, EMA, ICH).
• Establish and monitor eQMS performance metrics.

Skills

Quality systems leadership

Coaching and development

Change management

Communication skills

Problem solving

Project management

Adaptability

CSV knowledge

Veeva experience

Education

BS in a scientific discipline

Tools

Veeva

CSV principles

eQMS systems

Job description

Wave Life Sciences is seeking a Director of Quality Systems to lead foundational quality processes, including GxP training, document control, vendor management, and the eQMS. This onsite role requires four days per week at the Lexington, MA facility to support GMP-focused activities and broader GXP work as Wave moves toward commercialization.

The role demands a BS in a scientific discipline, 10–12 years in QA in pharma with 5+ years managing staff, and deep experience implementing and improving