Senior Director, Quality Management Systems & Compliance (Biotech)

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

Base salary: $251,771–$307,721 USD per year, plus performance-based annual bonus and equity compensation

Company

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

What you will do

• Set strategic direction for the global quality management system and digital compliance initiatives.
• Lead QMS governance, GxP standards, quality planning, management reviews, complaints, recalls, and continuous improvement across cell and gene therapy modalities.
• Develop risk-based compliance approaches, support inspection readiness, interact with Health Authorities, and draft responses to regulatory observations.
• Define global quality metrics and KPIs, evaluate QMS health, and use analytics to guide strategic decisions.
• Partner with IT and systems owners on compliant GxP computer system lifecycles under 21 CFR 11, Annex 11, and GAMP 5.
• Lead, mentor, and coordinate cross-functional quality experts while managing product complaint handling activities.

Requirements

• 15+ years of pharmaceutical industry experience with quality compliance leadership across research and development, commercial manufacturing, pharmacovigilance, and information quality.
• Deep knowledge of GxP regulations, QMS frameworks, and regulatory requirements across multiple therapeutic modalities.
• Experience leading organizational transformation, regulatory inspections, Health Authority interactions, and global work with agencies such as the FDA and EMA.
• Experience across small molecule, cell, and gene therapy modalities.
• Advanced knowledge of data analytics and performance management systems, with strong strategic thinking and cross-functional leadership skills.
• Bachelor's, master's, or doctoral degree in science, engineering, pharmacy, or medicine.

Culture & Benefits

• Mission-driven environment focused on developing curative genome editing treatments.
• Remote work arrangement associated with the Cambridge, Massachusetts location.
• Performance-based annual cash bonus and new hire equity grant.
• Eligibility for annual equity awards.
• Opportunity to influence quality culture and lead a high-performing team in an innovative environment.