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Quality Management Specialist

3 weeks ago

Exton, Pennsylvania, United States Frontage Laboratories Full time
About the Role

We are seeking an experienced Director of Quality Assurance, Pharmaceutical Manufacturing to join our team at Frontage Laboratories. As a key member of our organization, you will play a critical role in developing, implementing, and maintaining quality management systems that ensure our products meet the highest standards of quality and compliance.

Main Responsibilities
  • Develop and manage quality agreements with clients and suppliers.
  • Lead internal audits and provide recommendations for improvement.
  • Host regulatory inspections and respond to any findings or concerns.
  • Ensure the development and implementation of quality systems that align with global standards.

Requirements
  • BS or advanced degree in a scientific discipline or related area.
  • 10-15 years of experience in pharmaceutical/biotech industry, including manufacturing, development, and quality.
  • 6-8 years of experience in quality management and leadership positions.
  • Demonstrate strong knowledge of US, EMA, and ICH regulations, guidance, and industry standards for CGMP (21 CFR Part 210, 211).

About Frontage Laboratories
Frontage Laboratories Inc. is a leading Contract Research Organization (CRO) providing comprehensive services for pharmaceutical and biotechnology companies. We have over 25 state-of-the-art laboratories across the US, Canada, and China, offering expertise in drug metabolism, pharmacokinetics/pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Estimated Salary Range: $140,000 - $200,000 per year.