Overview In this role you will lead the enterprise-wide quality vision from clinical development through commercial operations, driving QMS modernization and digital transformation. You will act as executive sponsor for quality system initiatives and partner with R&D, Manufacturing, Regulatory Affairs, and Commercial Operations to enable rapid, compliant growth. You will shape data governance, AI/ML quality applications, and regulatory readiness, delivering quality-driven business value. This is an opportunity to influence the future of ATMPs and ensure world-class compliance at scale.
Compensation / Benefits- remote work (as indicated by )
- base salary with range
- performance-based annual cash bonus
- new hire equity grant
- eligibility for annual equity awards
- comprehensive benefits package
Responsibilities- Define and execute enterprise-wide QMS strategy aligned with objectives and growth
- Lead quality transformation initiatives supporting commercialization readiness
- Oversee governance structures and accountability models across the QMS
- Anticipate regulatory trends and position the organization for evolving requirements
- Champion quality excellence as a differentiator and driver of business value
- Lead governance, change management, and cultural maturity for quality
- Design and scale QMS from clinical to commercial stages with ATMP focus
- Oversee eQMS implementation, validation, and data integrity programs
- Ensure regulatory inspection readiness and support regulatory submissions
- Establish enterprise risk management integrating quality into corporate risk frameworks
- Drive KPI development for QMS performance and data-driven decisions
- Lead IT quality, CSV, and data governance initiatives for GxP systems
- Represent Quality in executive forums and cross-functional leadership
- Help build a high-performing, diverse quality organization
- Foster cross-functional partnerships with R&D, Regulatory, Supply Chain, etc.
Key requirements- 15-20+ years of quality leadership in Cell & Gene Therapy, biotech, or pharma
- Experience leading multiple regulatory approvals and commercial launches
- Expert knowledge of FDA, EMA, PMDA, and global health authority regulations
- Deep expertise in ICH guidelines (Q8, Q9, Q10, Q11), Part 11, Annex 11 and related frameworks
- Proven track record implementing enterprise-wide eQMS and digital transformation
- Strong background in Computer System Validation, data integrity, and digital compliance
- Advanced quality methodologies (Lean Six Sigma, FMEA, RCA)
- Experience with AI/ML in quality, predictive analytics, and digital twins
- Executive presence and ability to influence at all organizational levels
- BS/MS/PhD in science, engineering, pharmacy, or medicine
- Strategic thinking
- Cross-functional collaboration
- Change management
- eQMS implementation and optimization
- CSV and GxP computer systems lifecycle
- Data integrity governance
