Senior Director, Quality Systems (Biotech)

TL;DR

Senior Director, Quality Systems (Biotech): Providing strategic leadership and oversight for the global Quality Management System (QMS) with an accent on GxP compliance, risk management, and organizational scalability. Focus on driving digital transformation, ensuring regulatory alignment across diverse modalities, and fostering a culture of quality by design.

Location: Must be based in or able to commute to Boston, MA (Hybrid or On-Site).

Salary: $213,600 – $320,400

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Provide strategic vision and oversight for the global Quality Management System across all GxP domains and product modalities.
• Lead and mentor a team of Quality Systems Owners to ensure the health, integrity, and effectiveness of defined quality systems.
• Drive enterprise-wide alignment on quality standards, risk management, and continuous improvement initiatives.
• Partner with cross-functional leadership to integrate quality into business processes, including digital enablement and emerging technology adoption.
• Champion a culture of quality, accountability, and transparency across the organization.
• Manage regulatory interactions and ensure inspection readiness across multiple global regions.

Requirements

• BS, MS, JD, MD, or PhD in a Life Sciences discipline.
• Minimum 15 years of relevant work experience, including 7 years in a leadership/supervisory role.
• At least 10 years of QA leadership experience in a sponsor or contract organization.
• Deep expertise in global regulations, ICH guidance, and GxP operational oversight.
• Ability to travel up to 15%.
• Must be authorized to work in the United States.

Nice to have

• Experience with Lean, DMAIC, or Six Sigma methodologies.
• Direct experience with regulatory authorities.
• Background in both preclinical and clinical CMC processes.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• 401(k) retirement plan with company matching.
• Educational assistance programs and student loan repayment support.
• Commuting subsidy and charitable donation matching.
• Flexible work environment with hybrid options.