Quality Systems Lead
hace 2 semanas
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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