Quality Systems Lead

hace 2 semanas


Puerto Diablo Barrio, Puerto Rico Jobleads-Us A tiempo completo

About the Role

We are seeking a highly experienced Quality Systems Lead to join our team at PepGen. As a key member of our quality assurance group, you will be responsible for further developing and maintaining our quality management systems.

Key Responsibilities

  • Develop and maintain supplier management programs, including qualification assessments, auditing, quality agreements, and supplier lists.
  • Ensure continued compliance with FDA and other applicable regulations.
  • Oversee the supplier audit schedule, schedule and perform quality audits of GCP, GLP, and GMP vendors.
  • Evaluate, track, and maintain quality agreements as per internal procedure.
  • Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations.

Requirements

  • Bachelor's in Science, Engineering, or a related discipline is required.
  • Minimum of 8 years of relevant work experience in a pharmaceutical/biotech environment.
  • GCP/GMP/GLP quality assurance experience in the pharmaceutical or biotechnology industry.
  • Understanding of GMP regulatory requirements and implementation (FDA, ICH, EMA, etc.).

What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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