Associate Director, GMP Operational Quality (Biologics)

TL;DR

Associate Director, GMP Operational Quality (Biologics): Leading strategic and operational quality oversight for complex drug substance programs with an accent on cross-functional collaboration and regulatory compliance. Focus on managing CDMO relationships, resolving complex deviations, and ensuring robust quality systems for external manufacturing operations.

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

Salary: $94,600 - $141,800

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and patient-focused drug development.

What you will do

• Lead cross-functional teams to resolve complex deviations and ensure alignment with patient safety and regulatory standards.
• Provide quality oversight for external drug substance manufacturing, including CDMO and supplier management.
• Draft, negotiate, and oversee Quality Agreements to ensure procedural and regulatory compliance.
• Review and approve complex investigations, CAPAs, and batch records to support product disposition.
• Analyze quality metrics to identify risks and drive continuous improvement across quality systems.
• Provide technical guidance during regulatory agency audits and major development milestones.

Requirements

• Bachelor's degree in a scientific or allied health field.
• 8+ years of relevant GMP Quality experience in a biologics pharmaceutical setting.
• Proven leadership in managing complex quality initiatives and QA oversight of external manufacturing.
• Deep understanding of cGMP principles and global manufacturing requirements.
• Strong ability to influence matrixed teams and make risk-based decisions.
• Experience with electronic document management systems like TrackWise or Veeva.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs, including student loan repayment.
• 401(k) retirement plan with company matching.
• Flexible work arrangements with hybrid options.
• Supportive environment focused on professional growth and wellbeing.