Vice President, Quality

Sanegene Bio is a global, venture-backed, clinical-stage biotech company advancing best-in-class genetic medicines. Powered by our proprietary LEAD™ siRNA delivery and chemistry platform, we are developing innovative RNAi therapeutics for autoimmune, cardiovascular, obesity and metabolic diseases. With R&D operations across the U.S. and China, we foster a culture of scientific rigor, collaboration, operational excellence, and continuous innovation.

We are seeking an experienced Vice President, Quality to shape and lead Sanegene Bio’s global R&D Qual-ity strategy and capabilities across all GxP domains in support of our growing, multi-stage development pipeline. Reporting to the Chief Executive Officer and serving as a member of the Leadership Team, the VP Quality will provide independent quality oversight while building right-sized, phase-appropriate quali-ty infrastructure aligned with the company's GxP commitments.

The VP Quality will partner closely with cross-functional leaders to ensure quality considerations are integrated into strategic decision-making, operational execution, and long-term business planning.

This role is accountable for the effectiveness and continuous improvement of the Quality Management System (QMS), quality governance, regulatory commitments, inspection readiness, quality oversight of clinical supply disposition, and quality culture across all sites. The VP Quality will define and execute an enterprise-wide quality vision that enables the organization to grow from preclinical and early clinical development into global Phase II/III trials, registration, and commercial readiness while maintaining com-pliance with global regulatory requirements.

Organizational Scope and Strategic Leadership Responsibilities

Serve as advisor to the CEO and Leadership Team on significant quality and compliance risks, providing clear, risk-based recommendations.

Lead and develop the existing China-based Quality team and build a phase-appropriate, solutions-oriented R&D Quality organization grounded in scientific credibility and operational excellence.

Serve as the primary global Quality interface connecting teams in the U.S. and China, Health Authorities, and CRO/CDMO partners.

Provide hands-on quality leadership for the China-based team and partners, including regular overlap with China business hours and periodic on-site presence.

Develop and manage departmental operating and capital budgets to ensure effective allocation of resources.

Own the Quality Management System; strengthen and scale it in line with regulatory requirements and applicable global standards, keeping processes practical and rigorous without unnecessary bureaucracy.

Lead harmonization of a single global QMS across U.S. and China operations, including selection and implementation of an electronic QMS (eQMS).

Oversee core GxP quality systems, including deviations, investigations, CAPAs, change control, audits, data integrity, training, vendor qualification, and management review.

Establish phase-appropriate quality metrics, analytics, and reporting capabilities that enable proactive risk management and data-driven decision-making.

Foster a quality culture that values innovation, continuous improvement, and personal accountability.

Lead inspection readiness programs to ensure the organization is continuously prepared for regulatory inspections and partner audits.

Serve as the Quality leader and inspection host during global regulatory inspections (e.g., FDA, EMA, MHRA, NMPA), ensuring timely, effective responses and resolution of findings.

Maintain robust governance of contract organizations, critical suppliers, and service providers, including negotiating and managing quality agreements with CDMOs,…