Vice President, Quality Management Systems and Digital Compliance
Intellia Therapeutics, Inc.
August 22, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities
- Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans; serve as executive sponsor for quality system transformation initiatives.
- Lead long-term planning for quality infrastructure investments, technology roadmaps, and capability building; anticipate regulatory trends.
- Lead enterprise quality transformation and change management; establish governance, decision-making frameworks, and accountability models.
- Design, implement, and scale comprehensive QMS from clinical through commercial stages (ATMPs focus); maintain QMS strategic roadmap.
- Provide executive oversight for deviations, CAPA, change control, document control, complaints, quality risk management, and data integrity.
- Chair Quality Management Review; define KPIs and drive continuous improvement using quality analytics.
- Lead eQMS digital transformation; oversee IT Quality, Computer System Validation (CSV), and data integrity to comply with 21 CFR Part 11, Annex 11, and GAMP 5.
- Ensure inspection readiness (global inspections/PAIs); lead health authority inspections and third-party GMP audits; support regulatory submissions/dossiers.
- Establish enterprise risk management; champion QbD and risk-based thinking; implement QMS effectiveness metrics.
- Build and lead a high-performing quality team; mentor leaders; drive DEI initiatives.
- Partner with R&D, Technical Ops, Supply Chain, Regulatory Affairs, and Commercial Ops; collaborate with Legal/Finance/Corp Dev and HR.
Qualifications / Skills
- Expert knowledge of FDA, EMA, PMDA, and ROW regulations for pharmaceuticals and ATMPs; deep ICH (Q8–Q11), 21 CFR Part 11, and EU GMP Annex 11 expertise.
- Proven leadership in eQMS/digital transformation (implementation, validation, optimization); strong data integrity and CSV knowledge.
- Advanced quality methodologies: Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis.
- Strong analytics/BI and quality dashboard proficiency; knowledge of AI/ML in quality and predictive analytics.
- BS/MS/PhD in science/engineering/pharmacy/medicine.
- 15–20+ years quality leadership in Cell & Gene Therapy/biotech/pharma; 10+ years managing quality systems and compliance; experience scaling clinical-to-commercial quality.
- Direct experience with regulatory approvals, commercial launches, and regulatory inspections.
Application Instructions
- Apply on a rolling basis until the position is filled.
- Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans; serve as executive sponsor for quality system transformation initiatives.
- Lead long-term planning for quality infrastructure investments, technology roadmaps, and capability building; anticipate regulatory trends.
- Lead enterprise quality transformation and change management; establish governance, decision-making frameworks, and accountability models.
- Design, implement, and scale comprehensive QMS from clinical through commercial stages (ATMPs focus); maintain QMS strategic roadmap.
- Provide executive oversight for deviations, CAPA, change control, document control, complaints, quality risk management, and data integrity.
- Chair Quality Management Review; define KPIs and drive continuous improvement using quality analytics.
- Lead eQMS digital transformation; oversee IT Quality, Computer System Validation (CSV), and data integrity to comply with 21 CFR Part 11, Annex 11, and GAMP 5.
- Ensure inspection readiness (global inspections/PAIs); lead health authority inspections and third-party GMP audits; support regulatory submissions/dossiers.
- Establish enterprise risk management; champion QbD and risk-based thinking; implement QMS effectiveness metrics.
- Build and lead a high-performing quality team; mentor leaders; drive DEI initiatives.
- Partner with R&D, Technical Ops, Supply Chain, Regulatory Affairs, and Commercial Ops; collaborate with Legal/Finance/Corp Dev and HR.
Qualifications / Skills
- Expert knowledge of FDA, EMA, PMDA, and ROW regulations for pharmaceuticals and ATMPs; deep ICH (Q8–Q11), 21 CFR Part 11, and EU GMP Annex 11 expertise.
- Proven leadership in eQMS/digital transformation (implementation, validation, optimization); strong data integrity and CSV knowledge.
- Advanced quality methodologies: Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis.
- Strong analytics/BI and quality dashboard proficiency; knowledge of AI/ML in quality and predictive analytics.
- BS/MS/PhD in science/engineering/pharmacy/medicine.
- 15–20+ years quality leadership in Cell & Gene Therapy/biotech/pharma; 10+ years managing quality systems and compliance; experience scaling clinical-to-commercial quality.
- Direct experience with regulatory approvals, commercial launches, and regulatory inspections.
Application Instructions
- Apply on a rolling basis until the position is filled.