<p>Description</p> <p>The Company:</p> <p>Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.</p> <p>We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, manufacturing and CMC.</p> <p>Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.</p> <p>The Role:</p> <p>We are seeking a strong QA inspection readiness leader with a demonstrated track record to lead and support global inspection readiness initiatives across GxP domains (GMP, GCP, GLP, etc.) with an immediate focus on U.S. clinical trial activities. The Inspection Readiness Lead will report to the Vice President, Legal and Compliance and will have overall responsibility for the company's preparedness for regulatory authority inspections. The ideal candidate will bring deep expertise in inspection readiness, quality systems, and regulatory requirements and expectations and will play a critical role in preparing the organization for successful regulatory inspections and third-party audits.</p> <p>Key Responsibilities:</p> <ul> <li>Create overall plan to prepare all necessary elements of the company and suppliers for regulatory inspections </li><li>Conduct gap assessments of quality systems, documentation, and processes and lead mitigation and remediation efforts </li><li>Drive inspection readiness to meet timelines and assist cross-functionally in prioritizing activities </li><li>With management team, designate ownership and ensure accountability for inspection readiness activities, including cross-functionally across the Quality and TMF groups, other functional groups, and vendors </li><li>Regularly inform management and team members of project progress and elevate issues as needed </li><li>Manage contractors performing inspection readiness audits, trainings, and other preparedness activities </li><li>Coordinate mock regulatory inspections simulating agency expectations </li><li>Prepare teams and SMEs for inspection roles through training, coaching, and simulation of interviews and inspection scenarios </li><li>Facilitate the development of inspection procedures, storyboards, and other inspection tools </li><li>Lead or support inspection hosting duties during regulatory inspections or audits </li><li>Coordinate responses to inspection and audit findings </li></ul> <p>Requirements</p> <ul> <li>8+ years of experience in QA or compliance in the pharmaceutical/biotech industry </li><li>Bachelor's degree required </li><li>Extensive experience leading regulatory inspections with a focus on GCP/BIMO, including preparing clinical sites, service providers and vendors </li><li>Hands-on experience conducting mock audits, internal audits, and inspection simulations </li><li>Strong understanding of global GxP regulations and ICH guidelines </li><li>Proficient in identifying risk areas and developing strategic remediation and training plan </li><li>Excellent communication, organizational, and interpersonal skills </li><li>Familiarity with both pre-commercial and commercial stage regulatory expectations </li></ul>