Vice President, Quality

Position Overview

SanegeneBio 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 SanegeneBio’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.

Key Responsibilities

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, CROs, and other partners.

• Oversee a risk-based audit program for CROs, CDMOs, clinical sites, and other third-party vendors.

• Lead quality due diligence and quality support for business development and partnering activities, including quality agreements and audits with licensing and co-development partners.
  

Manufacturing Responsibilities

• Provide phase-appropriate governance and oversight of cGMP activities across internal operations and external manufacturing partners.

• Provide executive oversight of batch record review, deviations, investigations, CAPAs, and change control.

• Provide quality oversight of clinical supply disposition, ensuring drug substances, intermediates, and drug products are manufactured, tested, and released in accordance with cGMP and global regulatory requirements.

• Provide executive leadership for supplier quality, manufacturing quality, and laboratory quality capabilities, including effective qualification and ongoing oversight of suppliers and raw materials.

• Ensure appropriate CMC quality support for regulatory submissions, including review of quality-related content in IND/IMPD and other global filings.

• Prepare the organization for late-stage development and registration, including quality oversight of process validation (PPQ), stability programs, and pre-approval inspection (PAI) readiness.

• Partner with Supply Chain and Procurement to strengthen supply chain resilience and risk mitigation strategies.

• Manage relationships with external consultants and other third-party service providers (e.g., CDMOs and contract testing laboratories), including determining when and how to engage outside support as the organization scales.

Clinical and Nonclinical Responsibilities

• Provide enterprise governance and oversight of GLP, GCP, and GVP activities.

• Define a robust, phase-appropriate quality strategy for nonclinical and clinical development programs, aligned with global regulatory requirements.

• Embed risk-based quality management principles into study design, data generation, and clinical and nonclinical vendor oversight.

• Ensure quality approaches effectively support the execution of global clinical trials, including CRO oversight and GCP compliance.

• Establish GCP and GLP quality objectives and metrics and provide strategic quality reporting to senior leadership.

• Plan, conduct, and report on audits of clinical sites, CROs, nonclinical laboratories, and pharmacovigilance vendors.

• Oversee pharmacovigilance quality activities and vendor oversight to ensure compliance, data integrity, and effective safety surveillance.

• Review and approve clinical protocols, informed consent forms, clinical product labels, and the clinical quality aspects of regulatory submissions.

• Identify emerging compliance and quality risks and assess their potential impact on development programs and regulatory submissions.
  

Qualifications

• Bachelor's or Master's degree in a life science or related field; advanced degree (e.g., Ph.D.) pre-ferred.

• 15+ years of progressive quality experience in the biotechnology or pharmaceutical industry, spanning multiple GxP disciplines.

• Minimum of 5 years of people leadership and management experience, ideally leading a Quality function and managing remote or cross-regional teams.

• Excellent working knowledge of current GMP, GCP, GLP, and GVP requirements.

• Extensive knowledge of FDA, EMA, MHRA, NMPA, and PMDA regulations and ICH guidelines, with a strong understanding of the pharmaceutical product development lifecycle.

• Proven track record of hosting and managing global Health Authority inspections, audits, and quality interactions.

• Demonstrated success building and scaling a phase-appropriate QMS in a growing biotech envi-ronment.

• Demonstrated experience managing quality in a highly outsourced model, including oversight of global CRO and CDMO partners.

• Strong leadership skills, with the ability to influence and collaborate effectively across functions, cultures, and geographies.

• Excellent written and verbal communication and documentation skills.

• Prior experience with oligonucleotide or siRNA development programs preferred.

• Experience supporting late-stage development (Phase III, PPQ, NDA/MAA submissions, pre-approval inspections) strongly preferred.

This role is based in SanegeneBio's Woburn, MA office and requires travel (approximately 15% of the time) to the company's offices in China and to global vendors and partners.

Interested candidates: please send your information to hr@sanegenebio.com.