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Director, Quality (GCP/GCLP/GVP)

Date Posted: May 17, 2026
Yearly: USD - USD
Job is expired

Job Detail

  • location_on
    Location New Philadelphia, Pennsylvania, United States of America
  • desktop_windows
    Job Type: Permanent
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
  • calendar_view_day
    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
  • calendar_month
    Apply Before: Jun 17, 2026
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Job Description

Overview

Larimar Therapeutics Inc. is seeking a Director of Quality (GCP/GCLP/GVP) to enhance and oversee the Quality Management System in clinical product development and studies, as part of their mission to develop innovative treatments for rare diseases. The role involves cross-functional collaboration to manage regulatory risks and ensure compliance with global regulations.

Key responsibilities

  • Develop and execute the risk-based audit strategy for Clinical and Pharmacovigilance programs
  • Oversee external audits of GCP/GCLP/GVP vendors and clinical trial sites
  • Lead internal GCP/GCLP/GVP audits
  • Collaborate with CROs and service providers to ensure Quality Agreements are in place
  • Develop and monitor a Risk Management Program for clinical studies
  • Report potential or confirmed violations to regulatory authorities
  • Provide GCP guidance and training to internal teams
  • Manage evaluation of new GCP/GCLP/GVP regulations
  • Support inspection readiness preparation and regulatory agency inspections
  • Assist in compiling information for regulatory submissions and conducting quality reviews

Required skills

  • Bachelor's degree in life sciences
  • 10+ years of experience in a Quality role in biotechnology or pharmaceutical environments
  • Experience managing GCP/GCLP/GVP quality processes
  • Demonstrated experience with GCP inspections and audits
  • Expert knowledge of GxP systems and related regulations
  • Strong attention to detail and ability to work independently and collaboratively
  • Initiative in process improvements

What the company offers

  • Incentive stock options
  • Comprehensive benefits plan including 401K
  • Flexible PTO policy

Skills Required

Company Overview

Larimar Therapeutics
New Philadelphia, Pennsylvania, United States of America
2 Current Jobs Openings

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients with rare diseases. The company's expertise lies in its novel cell-penetrating peptide technology platform and aims to lea... Read More

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