Director, QA GMP Operations

Location: Onsite in Waltham, Massachusetts, United States

Salary: $188,000–$230,000 USD annually

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to address 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, OOS and OOT investigations in accordance with cGMP principles and ICH guidelines.
• Review batch records, analytical method reports, technical reports, and regulatory sections of IND/IMPD and BLA/MAA submissions.
• Provide QA support for technology transfer and process validation activities, including GMP batch disposition and interaction with the Qualified Person.
• Manage change controls and CDMO performance against Quality Agreements and GMP requirements.
• Drive continuous improvement, inspection readiness, pre-approval inspection preparation, and commercial readiness across CDMOs and internal operations.

Requirements

• BA/BS degree.
• 10+ years of experience in GMP Quality Operations within a late-stage clinical and/or commercial biotechnology company.
• Leadership experience with cross-functional teams and the ability to influence priorities and resource allocation without direct authority.
• Experience with outsourcing and support models, product batch disposition, and interaction with a Qualified Person.
• Strong written, oral, presentation, organizational, collaboration, and interpersonal skills.
• Ability to manage priorities, drive timelines, meet firm deadlines, and adapt to changing requirements.

Culture & Benefits

• Work with internal business stakeholders and Quality functions to advance compliant program outcomes.
• Promote collaboration, engagement, quality outcomes, and operational excellence.
• Equal opportunity employment is provided in accordance with applicable law.