Executive Director/AVP/Vice President, Quality Assurance

The Executive Director, Quality Assurance will lead the strategies for continuous improvement of Sironax’s global Quality Management System (QMS) to support a growing clinical-stage biotech organization progressing toward late-stage development and IPO readiness.

This leader will ensure end-to-end GxP compliance across clinical, preclinical, regulatory, and corporate functions while building scalable infrastructure to support global operations (U.S., EU, APAC). The role requires a strategic builder who can operate both at the executive level and in the details, establishing systems, leading inspections, and embedding a “One Sironax” quality culture. This leadership role will contribute to Sironax’s ability to advance clinical programs compliantly, successfully navigate global regulatory inspections, and establish a durable, scalable quality foundation for long-term growth

Quality Strategy & Leadership

• Define and execute risk-based global quality strategy aligned with corporate milestones
• Serve as a core member of the Regulatory & Quality leadership team
• Build and lead a high-performing global QA organization across U.S. and international regions
• Drive a culture of quality, inspection readiness, and continuous improvement

Quality Systems (QMS) & Compliance

• Oversees development and implementation of a fully integrated global eQMS and eTMF compliant with F ICH guidelines
• Oversee development and lifecycle management of:
  • SOPs, policies, and work instructions
  • Document control systems
  • Training programs and compliance tracking
• Ensure alignment of global processes with regional regulatory requirements

GxP Oversight (GCP, GLP, GVP, GMP as applicable)

• Provide oversight of clinical quality (GCP) across all trials
• Provide robust oversight of CROs, CMOs, and critical vendors, implementing vendor performance metrics and quality agreements
• Support GLP oversight for preclinical programs and toxicology studies
• Ensure readiness for pharmacovigilance quality (GVP) as pipeline advances
• Participate in vendor selection and governance processes where appropriate

Audit & Inspection Readiness

• Develop and execute a risk-based internal and external audit program
• Lead regulatory inspections (FDA, EMA, NMPA, PMDA, etc.) and ensure successful outcomes
• Oversee vendor qualification and audit programs (CROs, CMOs, labs, technology vendors)
• Drive CAPA management, root cause analysis, and continuous improvement initiatives

Data Integrity & Compliance Infrastructure

• Ensure ALCOA+ data integrity principles across all GxP systems
• Partner with IT to validate and maintain compliant systems (e.g., eTMF, EDC, safety systems, eQMS)

Cross-Functional & Global Collaboration

• Partner with Clinical Operations (trial execution & oversight), Regulatory Affairs (submissions & inspections), Preclinical/Toxicology (GLP compliance), CMC (quality for manufacturing readiness as pipeline evolves)
• Align global teams under consistent quality standards while respecting local regulations (e.g., China data localization)

Education & Experience

• Bachelor’s degree in life sciences required; advanced degree (MS, PhD, PharmD) preferred
• 15+ years of Quality Assurance experience in startup biotech and pharma
• 8+ years in leadership roles, with direct team management
• Demonstrated experience building or scaling a QMS in a clinical-stage biotech

Core Expertise

• Deep knowledge of:
  • GCP, GLP, GVP, and applicable GMP interfaces
  • FDA, EMA, ICH, and global regulatory frameworks
• Proven success leading regulatory inspections (FDA/EMA strongly preferred), global audit programs and eQMS and eTMF implementation and optimization

Leadership Capabilities

• Strategic thinker with hands-on execution capability
• Strong executive presence; ability to interact with CEO, Board, and regulators
• Skilled at influencing cross-functional teams without direct authority
• Experience operating in fast-paced, resource-constrained environments

Key Success Metrics (First 12-18 Months)

• Successful development of quality management plans for ongoing trials
• Successful execution of internal audits and mock inspections
• Demonstrated inspection readiness across all active programs
• Strong vendor oversight framework with measurable quality KPIs
• Establishment of a scalable QA organization aligned to pipeline growth