Vice President, Quality Management Systems and Digital Compliance

Location: Remote, associated with Cambridge, Massachusetts, United States

Salary: $319,064–$389,968 USD per year, plus performance-based annual bonus and equity compensation

Company

hirify.global develops genome editing treatments for severe and life-threatening diseases.

What you will do

• Define and execute the enterprise-wide quality management system strategy from clinical development through commercial operations.
• Lead quality transformation, governance, change management, and organizational capability building.
• Design, implement, validate, and scale eQMS infrastructure for advanced therapy medicinal products.
• Oversee deviations, CAPA, change control, document control, complaints, quality risk management, data integrity, and quality analytics.
• Lead inspection readiness, health authority inspections, third-party GMP audits, regulatory submissions, and product licensing support.
• Build and lead a high-performing quality organization and partner with R&D, manufacturing, supply chain, regulatory, commercial, legal, finance, and HR leadership.

Requirements

• 15–20+ years of quality leadership experience in cell and gene therapy, biotechnology, or pharmaceuticals, including 10+ years managing quality systems and compliance functions.
• Expert knowledge of FDA, EMA, PMDA, and other global health authority requirements for pharmaceuticals and advanced therapy medicinal products.
• Deep knowledge of ICH Q8, Q9, Q10, and Q11, 21 CFR Part 11, EU GMP Annex 11, and emerging regulatory frameworks.
• Proven experience leading enterprise eQMS implementation, computer system validation, data integrity, digital compliance, regulatory inspections, approvals, and commercial launches.
• Advanced expertise in Lean Six Sigma, FMEA, root cause analysis, quality metrics, data analytics, and risk management.
• BS, MS, or PhD in science, engineering, pharmacy, medicine, or a related field, with executive presence and experience scaling quality organizations.

Nice to have

• Lean Six Sigma Black Belt certification.
• Experience with biologics, AI/ML applications in quality, digital twins, and predictive analytics.

Culture & Benefits

• Remote work arrangement.
• Performance-based annual cash bonus.
• New hire equity grant and eligibility for annual equity awards.
• Environment focused on curiosity, innovation, accountability, continuous improvement, and diversity, equity, and inclusion.