Director, Quality Management Systems (Biotech)

Location: Waltham, Massachusetts, United States; onsite

Salary: $196,000–$230,000 USD per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to address genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead the evolution of a commercial-ready, globally scalable QMS aligned with ICH Q10, FDA CFRs, and international regulatory standards.
• Establish inspection readiness and represent assigned QMS areas during regulatory inspections and health authority interactions.
• Own risk-based internal audits, systemic quality risk identification, CAPA development, closure, and effectiveness checks.
• Build and mature supplier qualification, monitoring, and oversight programs.
• Oversee the product complaint lifecycle, including intake, triage, investigation, escalation, and trending.
• Define quality metrics, drive continuous improvement, and govern validated eQMS and Learning Management Systems.

Requirements

• Bachelor’s degree in a scientific discipline or Quality Systems Management; an advanced degree is preferred.
• 10+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxP areas including GCP, GLP, GMP, and preferably GVP.
• Direct leadership and ownership experience across QMS and quality systems.
• Strong knowledge of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements.
• Experience implementing and managing eQMS platforms such as Veeva eQMS or MasterControl and Learning Management Systems.
• Strategic and operational leadership, risk management, communication, and the ability to influence senior and cross-functional stakeholders.

Culture & Benefits

• Hands-on leadership role combining strategic vision with operational execution.
• Cross-functional environment focused on accountability, transparency, quality ownership, and continuous improvement.
• Opportunity to help build a high-performing quality organization during the transition to commercial operations.