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Director, Quality (GCP/GCLP/GVP)

Larimar Therapeutics

Middle East, PA

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JOB DETAILS
SKILLS
Auditing, Biology, Biotech and Pharmaceutical, Business Strategy, Clinical Practices/Protocols, Clinical Support, Clinical Trial, Compensation and Benefits, Computer Telephony Integration (CTI), Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Detail Oriented, Disease, Disease Treatment, Drug Development, Employee Retention, Entrepreneurship, External Audit, FDA (Food and Drug Administration), FDA Requirements, GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), Genetics, GxP, Healthcare Quality, ICH Regulations, Information/Data Security (InfoSec), Leadership, Maintain Compliance, Manufacturing/Industrial Processes, Medical Products, Operational Support, People Management, Pharmacovigilance, Process Improvement, Product Development, Project/Program Management, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), Systems Administration/Management, Team Lead/Manager, Willing to Travel
LOCATION
Middle East, PA
POSTED
1 day ago
Description: The Company: 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 (formerly referred to as 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. The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position: Director, Quality (GCP/GCLP/GVP) Reports to: Sr. Director, Quality Job Responsibilities: Position Overview: The Director, Quality (GCP/GCLP/GVP) will play a key role in shaping and strengthening Larimar’s Quality Management System and advancing quality oversight across clinical product development and clinical studies. In this highly visible role, the candidate will collaborate cross-functionally to proactively manage GCP/GCLP/GVP regulatory risks, support inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes. This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements and relevant global GCP, GCLP and GVP regulations and guidelines. The Director, Quality (GCP/GCLP/GVP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company’s contractors, CROs, service providers, etc. to enable development, regulatory approval, and commercialization of the company’s products. This role reports to the Sr. Director, Quality. Key Responsibilities: Will include but are not limited to: Develops, implements, and executes the risk-based audit strategy for Clinical and Pharmacovigilance programs. Oversees/leads the execution and completion of external audits of GCP/GCLP/GVP vendors and clinical trial sites, including collaboration with the business sponsors to share audit findings. Leads internal GCP/GCLP/GVP audits. Collaborates with Quality representatives at Larimar’s CROs and service providers to ensure the appropriate Quality Agreements have been developed and implemented in support of Larimar’s clinical studies. Develops and monitors Larimar’s Risk Management Program for clinical studies. Ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate. Provides Good Clinical Practices (GCP) guidance and training to internal teams Manages evaluation of new GCP/GCLP/GVP related regulations and potential implications for Larimar. · Supports the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools ensuring consistency and compliance with relevant GCP, GCLP, CLIA, FDA, EMA, and other global regulatory requirements. Directly supports inspection readiness preparation (core team) and supports regulatory agency inspection(s). Assists in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested. Supports quality system monitoring reviews. Supports other Quality activities, as required. Approximately 15-20% travel required Requirements: Qualifications: Bachelor’s degree in life sciences with a minimum of 10 years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment Experience managing GCP/GCLP/GVP quality processes, including risk management activities Demonstrated experience managing GCP inspections, including preparation and response activities Minimum of 3 years experience performing GCP/GCLP/GVP audits or comparable GxP audit experience Expert knowledge of GxP systems, quality principles, and GCP/GCLP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) and ability to translate understanding to practice Demonstrated ability to initiate process improvements and take initiative is required Must possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI974b0e3d7f2c-25448-397972445c143e31-5e48-4549-b638-05792d185386

About the Company

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Larimar Therapeutics