Senior Director, Quality Control (Biotech)

Location: Waltham, MA, United States; onsite and not eligible for remote work

Salary: $240,000–$285,000 USD base pay range

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

• Define and execute Quality Control strategy for clinical and commercial manufacturing, pipeline advancement, and product lifecycle management.
• Oversee external testing laboratories, release and stability testing, Certificates of Analysis, reference standards, and laboratory performance.
• Lead analytical method transfers, qualifications, validations, specifications, stability programs, and analytical data review.
• Ensure GMP compliance and inspection readiness, represent Quality Control during inspections, and support analytical CMC content for regulatory submissions.
• Direct investigations involving out-of-specification and out-of-trend results, data integrity, change controls, CAPA, sterility, bioburden, endotoxin, and environmental monitoring.
• Build technical capabilities, recruit and mentor team members, and collaborate with manufacturing, quality, regulatory, supply chain, development, and project management functions.

Requirements

• Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field; an advanced degree is preferred.
• 15+ years of experience in Analytical Development and Quality Control, including significant leadership of people or a function.
• Strong GMP Quality Control experience with compendial and product-specific assays for antibodies and small molecules.
• Experience overseeing contract testing laboratories, analytical method lifecycle activities, release and stability programs, regulatory submissions, and inspection readiness.
• Knowledge of applicable ICH, FDA, and EU regulations, along with specifications, reference standards, data integrity, change controls, CAPA, and OOS/OOT investigations.
• Strong judgment, communication, negotiation, organizational, and stakeholder-influence skills in a complex, matrixed, fast-paced environment.

Culture & Benefits

• Collaborative work across Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management.
• Opportunity to shape QC capabilities supporting clinical development, commercialization, and future pipeline growth.
• Focus on accountability, continuous improvement, transparent communication, and high-quality execution.
• Base compensation range of $240,000–$285,000 USD, with individual compensation dependent on qualifications and experience.