Lead Biologics Quality Assurance Director

2 days ago


Cambridge, Massachusetts, United States Jobot Full time

Job Overview

We are a publicly traded biotechnology company developing innovative solutions for chronic dermatological diseases.

Salary and Benefits

$240,000 - $270,000 per year. Competitive salary, annual bonus, equity, ESPP, 401k program, medical/vision/dental benefits, and hybrid schedule.

Job Description

We seek a Senior Director of Quality Assurance (GMP) to provide quality oversight for our clinical development programs and manufacturing.

Key Responsibilities

  • Provide quality support and guidance for CMC programs
  • Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers
  • Ensure quality oversight of GMP suppliers
  • Review and approve extensive documentation, including master batch records, executed batch documentation, analytical test methods, specifications, stability protocols and reports, release testing COAs and reports, etc.
  • Investigate and manage potential quality impact of product complaints and temperature excursions
  • Contribute to the development of our QMS as needed
  • Ensure inspection readiness at GMP suppliers
  • Provide quality review and feedback on regulatory application submissions and agency responses/information requests
  • Continuous improvement of quality and compliance practices
  • Approximately 10-20% travel (domestic and international)

Qualifications

  • Bachelor's degree in a scientific field
  • 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
  • Expertise in biologics required
  • In-depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO)
  • Experience supporting early phase clinical through commercial manufacturing, including contract manufacturers
  • Ability to work in a fast-paced environment, prioritizing and managing multiple tasks simultaneously


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