Director of Compliance and Regulatory Affairs

5 days ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Description

The Director of Quality Assurance, Pharmaceutical Manufacturing is a senior-level position that requires extensive experience in quality management, pharmaceutical manufacturing, and regulatory affairs. As a key member of the Frontage Laboratories team, you will be responsible for ensuring the development, implementation, and maintenance of quality management systems that meet the highest standards of quality and compliance.

Main Responsibilities
  • Develop, implement, and oversee quality systems at Frontage manufacturing facilities.
  • Manage supplier qualification, including quality agreements and audit reports.
  • Provide staff annual GMP training and interpret government and agency guidelines.
  • Maintain and continuously improve the use of electronic quality management system, ZenQMS.

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 provider of contract research services for pharmaceutical and biotechnology companies. Our state-of-the-art laboratories offer a range of services, including 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: $160,000 - $220,000 per year.

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