Quality Assurance Leadership Opportunity in Biotechnology

3 weeks ago


Cambridge, Massachusetts, United States Jobot Full time
Job Overview

This Senior Director of Quality Assurance (GMP) role is available at a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.

Compensation:

$240,000 - $270,000 per year

Responsibilities
  • Provide quality support and guidance for CMC programs
  • Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers
  • Provide quality oversight GMP suppliers
  • Extensive document review and approval for master batch records, executed batch documentation, analytical test methods, specifications, stability protocols and reports, release testing COAs and reports, etc.
  • Review and support GMP investigations associated with lot-related deviations
  • Review change controls, CAPAs, OOS/OOT investigations
  • Perform lot disposition
  • Ensure that GMP quality documentation is securely archived and retrievable
  • Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
  • Contribute to the development of our QMS as needed
  • Ensure inspection readiness at our GMP suppliers
  • Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests
  • Continuous improvement of quality and compliance practices to ensure highest standards are maintained

Requirements

  • Bachelor's degree in a scientific field
  • 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
  • Expertise in biologics is 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 the use of contract manufacturers
  • Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously

About Us

We are a dynamic biotech company focused on developing innovative treatments for chronic dermatological diseases. We offer a competitive salary and benefits package, including a hybrid schedule with approximately 10-20% travel.



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