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Quality Systems Manager

2 months ago

Boston, Massachusetts, United States PepGen Full time
Job Overview

Manager, Quality Systems

Position Overview

The Manager of Quality Systems is responsible for the enhancement and upkeep of the quality management frameworks that support clinical trial operations at PepGen. Key responsibilities include the formulation and management of supplier oversight programs, which encompass qualification evaluations, audits, quality agreements, and the maintenance of supplier directories. This role necessitates exceptional written and verbal communication skills for effective interaction with internal and external stakeholders, colleagues, and leadership. The Manager ensures ongoing adherence to FDA regulations and other relevant compliance standards.

Key Responsibilities

  • Advance and oversee PepGen's Supplier qualification and Quality Assurance oversight protocols and practices.
  • Maintain 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 uphold quality agreements in accordance with internal procedures.
  • Establish and uphold internal protocols in alignment with FDA, ICH, EU, and other country-specific regulations.
  • Engage in Health Authority inspections.
  • Review Quality Systems as necessary, including Deviations, CAPAs, and Change Controls.
  • Facilitate Risk Assessment review meetings as required.
  • Evaluate and review External Change Notifications.
  • Communicate effectively with CMOs, CROs, and Contract Laboratories as needed.
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 sector.
  • Familiarity with GMP regulatory requirements and their implementation (FDA, ICH, EMA, etc.).
  • Experience in technical writing or investigative writing.
  • Proficiency in Microsoft Office applications, particularly Word and Excel.
  • Experience with Veeva is preferred.
  • Strong interpersonal and communication skills (both written and verbal), a collaborative team player, and adaptable without compromising quality.
  • Excellent organizational skills.
  • Ability to work autonomously and follow up on outstanding actions without prompting.
  • 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 for 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 leveraging this technology across a diverse range of indications through 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 receive consideration 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 operate in a hybrid model, requiring in-office attendance on designated days each week.

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

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