R&D Quality Assurance Leader (GxP & Inspections)

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

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 person will help strengthen the R&D quality framework and sponsor oversight of outsourced studies and services.

This role combines leadership with direct execution; successful candidate will deliver audits, inspection preparation, investigations, SOPs, and process

Qualifications

• Bachelor’s degree in a scientific or related discipline.
• 15+ years pharma/biotech quality exp with 10+ in a GxP environment.
• Broad GCP, GVP, GLP quality experience across Clinical, Nonclinical and PV.
• Experience overseeing outsourced development activities and sponsor oversight.
• Leading and hosting health authority inspections and remediation.
• SOP authorship and training development with process improvements.
• Knowledge of US/international GCP/GVP/GLP and data integrity.
• Experience with electronic QMS; Veeva preferred.

Responsibilities

• Provide GCP and GVP Quality guidance to Clinical Operations, Drug Safety, Data Management, Regulatory and partners.
• Identify and elevate risks to participant safety, data integrity, and regulatory compliance.
• Oversee clinical program quality and sponsor oversight of CROs and sites.
• Provide QA oversight of outsourced PV activities and safety documentation.
• Partner with owners to strengthen oversight records and resolve cross-functional issues.

Skills

GCP quality leadership

GVP quality leadership

GLP quality leadership

Audits & inspections

CAPA & remediation

SOP authorship

Regulatory oversight

Education

Bachelor’s degree in science or related field

Advanced degree preferred

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 person will help strengthen the R&D quality framework and sponsor oversight of outsourced studies and services.

This role combines leadership with direct execution; successful candidate will deliver audits, inspection preparation, investigations, SOPs, and process