Director, Quality Systems, Research & Development (Biotech)

TL;DR

Director, Quality Systems, Research & Development (Biotech): Leading and evolving the Quality Management System (QMS) for biotech R&D with an accent on regulatory licensure and inspection readiness. Focus on designing eQMS processes, driving quality risk management, and ensuring GxP compliance across clinical and pre-commercial activities.

Location: Must be based in the United States

Salary: $217,000 – $240,000

Company

A mission-driven global health organization specializing in biotech R&D and late-stage development.

What you will do

• Lead the design, implementation, and improvement of the Quality Management System (QMS) for clinical and commercialization phases.
• Oversee eQMS processes including document control, training, deviations, CAPA, and change control.
• Establish quality governance frameworks, KPIs, and reporting systems to ensure transparency and compliance.
• Drive quality risk management practices aligned with ICH Q9 principles across operations.
• Lead inspection readiness activities and support health authority interactions (FDA, EMA, MHRA).
• Manage supplier quality oversight for CDMOs, CROs, and critical vendors.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field (advanced degree preferred).
• 12+ years of progressive experience in Quality Assurance within biotech, vaccines, biologics, or pharma.
• Proven experience building quality systems through late-stage development and commercialization readiness.
• Strong expertise in eQMS platforms, quality metrics, and global GxP requirements (21 CFR, ICH Q9, ICH Q10).
• Demonstrated success supporting regulatory inspections (FDA, BIMO, PAI).
• Must be based in the United States.

Culture & Benefits

• Competitive annual salary and 401(k) retirement plan with employer matching.
• Comprehensive medical, dental, and vision insurance coverage.
• Flexible vacation policy, sick leave, and paid time off.
• Flexible spending accounts (FSA) options.
• 10 federal holidays plus an end-of-year winter break.
• Inclusive and equal opportunity work environment.