Senior Director, R&D Quality Assurance

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.

Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform.  Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

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

This role combines leadership with direct execution. The successful candidate will bring broad GCP, GVP, and GLP Quality experience gained in a midsize to large biotechnology organization, take initiative with limited direction, and personally deliver audits, inspection preparation, investigations, SOPs, and process improvements. A collaborative approach, sound judgment, and consistent follow-through are essential.

Experience Bachelor’s degree in a scientific or related discipline, advanced degree preferred

At least 15 years of progressive pharmaceutical or biotechnology Quality experience, including at least 10 years in a GxP environment and demonstrated senior leadership responsibility

Broad, direct experience across GCP, GVP, and GLP Quality, including Clinical, Nonclinical, and Pharmacovigilance oversight in a midsize to large biotechnology organization

Demonstrated sponsor-side oversight of outsourced development activities and the ability to apply established quality practices in a growing organization

Substantial experience leading and hosting health authority inspections and managing inspection preparation, responses, and remediation

Proven experience conducting audits, writing clear audit reports, assessing CAPAs, and resolving significant quality issues

Demonstrated SOP authorship, training development, and implementation of process improvements that remain effective in routine operations

Working knowledge of applicable US and international GCP, GVP, and GLP requirements, data integrity principles, and electronic records controls

Experience with electronic QMS and document management systems, Veeva experience preferred

Responsibilities

Clinical and pharmacovigilance quality

Provide GCP and GVP Quality guidance to Clinical Operations, Clinical Development, Drug Safety, Data Management, Biostatistics, Regulatory, and other partners

Identify and escalate risks to participant safety, data integrity, and regulatory compliance

Oversee clinical program quality and sponsor oversight of CROs, investigator sites, laboratories, and specialty vendors, including assessment of risks related to monitoring, protocol deviations, informed consent, investigational product accountability, blinding, and essential records

Provide independent QA oversight of outsourced and internal PV activities, including safety case management, reporting processes, reconciliation, vendor…