R&D Quality Assurance Leader - GxP, Audits & Inspections

Wave Life Sciences; Lexington (MA); On-site; USD 236,000 - 320,000; Full time

Benefits offered by this job

Health insurance

401K with matching

Employee Stock Purchase Program

Generous PTO

Job summary

Wave Life Sciences seeks an experienced Quality leader to provide independent, risk-based oversight across Clinical, Nonclinical, and Pharmacovigilance activities. Reporting to the Executive Director, R&D Quality Assurance, this role combines leadership with hands-on execution to strengthen the R&D quality framework.

The ideal candidate has 15+ years in biotech/pharma quality, including 10+ years in a GxP environment, and a proven track record hosting inspections, writing audit reports, and

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• At least 15 years of progressive pharmaceutical/biotech Quality experience.
• 10+ years in a GxP environment with senior leadership responsibility.
• Broad experience in GCP, GVP, GLP across Clinical, Nonclinical, PV.
• Sponsor-side oversight of outsourced development activities.
• Experience leading health authority inspections and responses.
• SOP authorship, training development, and process improvements.

Responsibilities

• Provide GCP and GVP Quality guidance across Clinical Operations, Drug Safety, Data Management, and Regulatory.
• Identify risks to participant safety and data integrity; ensure regulatory compliance.
• Oversee CROs, investigator sites, labs, and vendors; assess monitoring and informed consent risks.
• Provide QA oversight of PV activities, including safety case management and reporting processes.
• Lead SOP development and CAPA processes; drive quality performance improvements.

Skills

Leadership

Regulatory communication

Audits & inspection readiness

Risk assessment

Cross-functional collaboration

Quality metrics

Education

Bachelor’s degree in science

Tools

Veeva

Electronic QMS

Job description

Wave Life Sciences seeks an experienced Quality leader to provide independent, risk-based oversight across Clinical, Nonclinical, and Pharmacovigilance activities. Reporting to the Executive Director, R&D Quality Assurance, this role combines leadership with hands-on execution to strengthen the R&D quality framework.

The ideal candidate has 15+ years in biotech/pharma quality, including 10+ years in a GxP environment, and a proven track record hosting inspections, writing audit reports, and