Senior Director, Quality Control (Biotech)

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

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

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 the Quality Control strategy supporting clinical and commercial manufacturing, pipeline advancement, and product lifecycle management.
• Oversee external testing laboratories, including release testing, stability programs, Certificates of Analysis, reference standards, and inspection readiness.
• Lead analytical method transfers, qualifications, validations, specifications, stability assessments, and regulatory Chemistry, Manufacturing, and Controls content.
• Direct investigations involving out-of-specification and out-of-trend results, data integrity, change controls, corrective and preventive actions, and root-cause analysis.
• Analyze laboratory performance and quality metrics, present risks and recommendations, and resolve complex issues with contract manufacturing and testing organizations.
• Recruit, coach, and mentor Quality Control personnel while building technical capabilities and promoting accountability and cross-functional collaboration.

Requirements

• Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field.
• 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, inspection readiness, and regulatory submissions.
• Experience with drug substance and drug product specifications, stability programs, reference standards, laboratory compliance systems, data integrity, CAPA, and OOS/OOT investigations.
• Ability to influence senior stakeholders, negotiate with external partners, make complex technical and compliance decisions, and operate in a highly matrixed environment.

Nice to have

• Advanced degree in chemistry, analytical chemistry, or a related discipline.

Culture & Benefits

• Collaborative, inclusive, and high-performing environment focused on quality, continuous improvement, and results.
• Cross-functional work with Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management.
• Professional development through coaching, mentoring, and career growth support.
• Equal opportunity employment environment.