Director, Quality (GCP/GCLP/GVP)

Company Overview

Larimar Therapeutics Inc. is a publicly traded clinical-stage biotechnology company developing therapies for people with complex rare diseases through its cell-penetrating peptide platform. Its lead candidate, Nomlabofusp (previously CTI-1601), is a subcutaneous recombinant fusion protein designed to deliver human frataxin (FXN) to the mitochondria of patients with Friedreich’s ataxia, a rare, progressive, and ultimately fatal genetic condition that limits FXN production.

The organization is led by a seasoned team with more than 20 years of pharmaceutical industry experience each, and it has a workforce of over 50 employees. Its collective expertise spans discovery, nonclinical and clinical development, regulatory affairs, and manufacturing process development under good manufacturing practices. Larimar aims to become a leader in rare disease treatment by applying its technology platform and scientific capability to nomlabofusp and future pipeline programs. The company emphasizes entrepreneurial thinking, scientific leadership, and a collaborative culture focused on execution.

Role Summary

The Director, Quality (GCP/GCLP/GVP) will help strengthen Larimar’s Quality Management System and expand quality oversight across clinical development and clinical studies. This highly visible role partners across functions to identify and manage regulatory risk in GCP, GCLP, and GVP environments, support inspection readiness, and drive continuous improvement using insights from audits, inspections, and changing regulatory expectations. The role also supports internal quality systems and procedures while ensuring alignment with Larimar requirements and applicable global regulations and guidelines. The position reports to the Senior Director, Quality and works closely with the broader Quality team, internal contractors, CROs, and service providers to support compliance, product development, regulatory approval, and future commercialization.

Key Responsibilities

• Build, implement, and carry out a risk-based audit plan for clinical and pharmacovigilance activities.
• Lead and complete external audits of GCP, GCLP, and GVP vendors as well as clinical trial sites, coordinating with business sponsors to communicate findings.
• Conduct internal audits across GCP, GCLP, and GVP areas.
• Work with Quality leaders at CROs and other service providers to ensure Quality Agreements are properly created and put into effect for Larimar’s clinical programs.
• Design and oversee Larimar’s clinical study risk management program.
• Ensure that suspected or confirmed compliance breaches are escalated to regulators when required.
• Provide GCP advice and training to internal stakeholders.
• Review new GCP, GCLP, and GVP regulations and assess how they may affect Larimar.
• Contribute to the creation and updating of quality, clinical, and pharmacovigilance procedures, SOPs, and risk assessment tools in line with GCP, GCLP, CLIA, FDA, EMA, and other global requirements.
• Support inspection-readiness activities as part of the core team and assist during regulatory inspections.
• Help gather information for regulatory submissions and perform quality reviews and audits of submissions when needed.
• Take part in quality system monitoring reviews.
• Support additional Quality-related tasks as needed.
• Travel approximately 15% to 20% of the time.

Requirements

• Bachelor’s degree in life sciences is required.
• At least 10 years of experience in a Quality function supporting Clinical Operations and/or Pharmacovigilance within biotechnology or pharmaceutical settings.
• Hands-on experience with GCP, GCLP, and GVP quality processes, including risk management.
• Proven background managing GCP inspections, including preparation and response.
• At least 3 years of experience conducting GCP/GCLP/GVP audits or similar GxP audits.
• Deep understanding of GxP systems, quality principles, and relevant regulations and guidance such as FDA, MHRA, EMA, and ICH GCP, with the ability to apply that knowledge in practice.
• Strong initiative with a track record of driving process improvements.
• Excellent attention to detail and the ability to work both independently and with others in a fast-moving environment.

Benefits

Larimar Therapeutics provides all employees with incentive stock options, a comprehensive benefits package that includes a 401(k), and a flexible PTO policy.

Equal Employment Opportunity

The company is committed to equal employment principles and values a professional, equitable workplace. Hiring, promotion, and employment decisions are based on merit, qualifications, performance, and business needs. Larimar seeks to attract, develop, and retain talented people from diverse communities. Employment decisions are made without unlawful discrimination based on age, race, color, national origin, gender, pregnancy or related medical conditions, gender identity or expression, religion, mental or physical disability, genetic information, marital status, veteran status, military status, sexual orientation, or any other protected characteristic under applicable law.