Director, QA GMP Operations

Location: Onsite in Waltham, Massachusetts, United States

Salary: $188,000–$230,000 USD per year

Company

Biotechnology company developing therapeutics for genetically driven neuromuscular diseases, including Duchenne muscular dystrophy, myotonic dystrophy type 1, facioscapulohumeral muscular dystrophy, and Pompe disease.

What you will do

• Manage external quality operations supporting clinical and commercial GMP manufacturing.
• Oversee deviations, out-of-specification and out-of-trend investigations in accordance with cGMP principles and ICH guidelines.
• Review batch records, analytical and technical reports, and regulatory sections of IND/IMPD and BLA/MAA submissions.
• Provide QA support for technology transfer, process validation, batch disposition, and Qualified Person interactions.
• Manage change control and CDMO performance against Quality Agreement and GMP requirements.
• Drive continuous improvement, inspection readiness, pre-approval inspection preparation, and commercial readiness across internal and external operations.

Requirements

• BA or BS degree.
• 10+ years of experience in GMP Quality Operations within a late-stage clinical or commercial biotechnology company.
• Leadership experience managing cross-functional teams and influencing priorities without direct authority.
• Experience with outsourcing and support models, product batch disposition, and Qualified Person interactions.
• Strong written, oral, presentation, organizational, collaboration, and stakeholder-management skills.
• Ability to manage deadlines, adapt to changing priorities, and assess the business impact of project decisions.

Culture & Benefits

• Collaboration with internal business stakeholders, Quality functions, CDMOs, and cross-functional subject-matter experts.
• Focus on operational excellence, compliance, quality outcomes, and inspection readiness.
• Onsite work environment in Waltham, Massachusetts.
• Equal opportunity employment.