Quality Systems Manager

1 month ago


Boston, Massachusetts, United States PepGen Full time
Job Title: Quality Systems Manager

At PepGen, we are seeking a highly skilled Quality Systems Manager to join our team. As a key member of our quality team, you will be responsible for developing and maintaining our quality management systems to support clinical trial activities.

Key Responsibilities:

  • Develop and manage supplier qualification and QA oversight programs and procedures
  • Maintain supplier databases and approved supplier lists
  • Oversee supplier audit schedules and conduct quality audits of GCP, GLP, and GMP vendors
  • Evaluate and maintain quality agreements as per internal procedures
  • Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
  • Participate in health authority inspections and review quality systems as needed
  • Conduct risk assessment review meetings and review external change notifications

Requirements:

  • Bachelor's degree in a relevant field, such as science, engineering, or a related discipline
  • Minimum of 8 years of relevant work experience in a pharmaceutical or biotechnology environment
  • GCP/GMP/GLP quality assurance experience in the pharmaceutical or biotechnology industry
  • Understanding of GMP regulatory requirements and implementation (FDA, ICH, EMA, etc.)
  • Technical writing or investigation writing experience
  • Strong aptitude with Microsoft Office applications, including Word and Excel
  • Veeva experience preferred
  • Strong interpersonal and communication skills, with the ability to work independently and as part of a team
  • Ability to travel required

About PepGen:

We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts.

EEO Statement:

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status, or liability for military status.


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