Quality Systems Manager

2 weeks ago

Boston, Massachusetts, United States PepGen Full time
Job Overview

Position Title: Manager, Quality Systems

Role Summary

The Manager of Quality Systems is responsible for the ongoing enhancement and management of quality assurance frameworks that support clinical trial operations at PepGen. Key duties involve the development and upkeep of supplier management protocols, which encompass qualification evaluations, audits, quality agreements, and maintaining the supplier roster. This role necessitates exceptional communication abilities, both written and verbal, to engage effectively with internal teams, external partners, and management. The Manager is tasked with ensuring adherence to FDA regulations and other relevant compliance standards.

Key Responsibilities

  • Enhance and oversee PepGen's supplier qualification and quality assurance oversight programs and procedures.
  • Maintain and update the Supplier Database and Approved Supplier List.
  • Manage the Supplier Audit Schedule.
  • Conduct quality audits of GCP, GLP, and GMP vendors.
  • Perform quality evaluations of GMP, GCP, and GLP vendor systems.
  • Assess, track, and maintain quality agreements in accordance with internal protocols.
  • Establish and uphold internal procedures in compliance with FDA, ICH, EU, and other relevant regulations.
  • Engage in Health Authority inspections as required.
  • Review Quality Systems as necessary, including Deviations, CAPAs, and Change Controls.
  • Facilitate Risk Assessment review meetings as needed.
  • Evaluate and respond to External Change Notifications.
  • Communicate effectively with CMOs, CROs, and Contract Laboratories as appropriate.

Qualifications

  • Bachelor's degree in Science, Engineering, or a related field is essential.
  • A minimum of 8 years of pertinent experience in a pharmaceutical or biotechnology setting.
  • Experience in GCP/GMP/GLP quality assurance within the pharmaceutical or biotechnology industry.
  • Comprehensive understanding of GMP regulatory requirements and their implementation (FDA, ICH, EMA, etc.).
  • Experience in technical writing or investigation documentation.
  • Proficient in Microsoft Office applications, particularly Word and Excel.
  • Familiarity with Veeva is preferred.
  • Strong interpersonal and communication skills (both written and verbal), with a collaborative mindset and adaptability without compromising quality.
  • Excellent organizational skills.
  • Ability to work autonomously and follow up on outstanding actions proactively.
  • Previous supervisory experience is preferred.
  • CQA certification is a plus.
  • Willingness to travel is required.


About PepGen

PepGen is a biotechnology firm dedicated to advancing next-generation oligonucleotide therapies aimed at treating neuromuscular disorders. Our goal is to unlock the potential of nucleic acid therapeutics by utilizing the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this innovative technology across a broad spectrum of indications through both independent and partnered development pathways and are actively expanding our team.

EEO Statement
PepGen is an Equal Opportunity Employer committed to fostering a culturally diverse workforce. All qualified candidates will be considered for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, sexual orientation, disability, veteran status, or military status.

Note: This position is not remote. We prioritize in-person collaboration and operate in a hybrid model, requiring office presence on designated days as business needs dictate.

Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. We are currently collaborating exclusively with The Bowdoin Group for all recruitment needs.

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