Associate Director, Quality Management Systems (Biotech)

Location: Waltham, MA; onsite

Salary: $160,000–$195,000 USD annually

Company

Develops therapeutics targeting muscle and the central nervous system for 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 Quality Management System aligned with ICH Q10, FDA CFRs, and international regulatory standards.
• Own the lifecycle management of quality documents, controlled records, and GxP documentation programs.
• Plan, deploy, and govern role-based training curricula, refresher training, cross-training, and learning materials.
• Implement, optimize, and govern validated eQMS and Learning Management Systems.
• Define and report quality metrics and KPIs while driving continuous improvement and risk reduction.
• Represent assigned QMS areas during regulatory inspections and health authority interactions, influencing cross-functional decisions without direct authority.

Requirements

• Bachelor’s degree in a scientific discipline or Quality Systems Management; an advanced degree is preferred.
• 8+ years of experience in biotechnology or pharmaceutical environments with exposure across GxPs, including GCP, GLP, GMP, and preferably GVP.
• Direct ownership of QMS and quality systems, with a deep understanding of FDA CFRs, ICH guidance, and EU Annex requirements.
• Experience implementing and managing eQMS platforms such as Veeva eQMS or MasterControl and Learning Management Systems.
• Ability to balance strategic vision with hands-on execution while managing multiple complex initiatives.
• Strong judgment, risk management, communication, stakeholder influence, autonomy, and accountability.

Culture & Benefits

• Quality is positioned as a strategic enabler of business performance and decision-making.
• Work emphasizes accountability, transparency, continuous improvement, and cross-functional collaboration.
• Opportunity to build and scale systems supporting the transition to commercial operations.