Vice President, Quality Management Systems and Digital Compliance (Biotech)

Location: Remote role associated with Cambridge, MA, United States

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

Company

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

What you will do

• Define and execute the enterprise-wide quality management systems strategy from clinical development through commercial operations, including advanced therapy medicinal products.
• Lead quality transformation, change management, governance, and organizational maturity initiatives as an executive partner to R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Commercial Operations.
• Oversee critical quality processes including deviations, CAPA, change control, document control, complaints, quality risk management, and data integrity.
• Lead eQMS adoption, validation, optimization, IT Quality, Computer System Validation, and GxP computer systems lifecycle compliance.
• Ensure global inspection readiness, lead health authority inspections and GMP audits, and support regulatory submissions, product licenses, and regulatory dossiers.
• Build and develop a high-performing quality organization, establish performance metrics, and foster accountability, innovation, and continuous improvement.

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 regulations, as well as ICH Q8, Q9, Q10, Q11, 21 CFR Part 11, and EU GMP Annex 11.
• Proven success leading eQMS implementation and digital transformation, Computer System Validation, data integrity, regulatory inspections, approvals, and commercial launches.
• Experience scaling quality organizations from clinical through commercial phases and leading teams through high-growth environments.
• Advanced knowledge of Lean Six Sigma, FMEA, root cause analysis, quality risk management, data analytics, business intelligence, and quality metrics dashboards.
• BS, MS, or PhD in science, engineering, pharmacy, medicine, or a related field; executive presence and ability to influence across organizational levels.

Nice to have

• Lean Six Sigma Black Belt certification.
• Experience with biologics and advanced therapy medicinal products.
• Experience applying AI/ML in quality, digital twins, and predictive analytics.

Culture & Benefits

• Mission-driven work focused on developing life-changing genome editing therapies.
• Values centered on exploration, disruption, delivery, collaboration, and high standards.
• Remote work arrangement.
• Performance-based annual cash bonus, new-hire equity grant, and eligibility for annual equity awards.
• Equal employment opportunity and reasonable workplace accommodations for qualified individuals with disabilities.

Hiring process

• Applications are accepted on a rolling basis until the position is filled.