Associate Director/Director, Quality Assurance
24 hours ago
Larimar Therapeutics is a clinical-stage biotechnology company dedicated to developing innovative treatments for patients with complex rare diseases. Our cutting-edge cell-penetrating peptide technology platform enables us to deliver essential proteins to the mitochondria, addressing the root cause of these debilitating conditions.
Our team of experienced professionals, each with over 20 years of pharmaceutical industry expertise, is committed to advancing our lead product candidate, Nomlabofusp, and other pipeline projects. We strive to become a leader in the treatment of rare diseases by leveraging our technology platform and scientific know-how.
Job SummaryWe are seeking an Associate Director/Director, Quality to join our Quality organization. This role will lead Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)-related Quality activities, ensuring compliance with global regulations and guidelines. The successful candidate will provide cross-functional support, manage internal quality systems, and collaborate with contractors, CROs, and service providers to ensure quality compliance.
Key Responsibilities- Provide GCP/GVP Quality oversight, guidance, and support to cross-functional teams.
- Manage compliance and study-specific risk assessments, facilitating root cause analysis, CAPA implementation, and effectiveness checks.
- Develop and execute a risk-based audit strategy for Clinical and Pharmacovigilance programs.
- Oversee/lead external audits of GCP/GVP vendors and investigator sites, and internal GCP/GVP audits.
- Conduct Quality reviews of GCP/GVP-related documentation, including study protocols, study plans, ICFs, study reports, and other clinical trial-specific documents.
- Collaborate with Quality representatives at CROs and service providers to ensure Quality Agreements and study plans are developed and implemented.
- Participate in clinical and safety-related team meetings.
- Support the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures.
- Assist in inspection readiness preparation and support regulatory agency inspections.
- Support evaluation of new GCP/GVP-related regulations and potential implications for Larimar.
- Lead investigations for GCP or GVP issues, including root cause identification and development of corrective and preventive actions.
- Support quality system monitoring reviews.
- Assist in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions.
This role requires a Bachelor's degree in life sciences with a minimum of 8+ years of experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment. A minimum of 2 years of experience performing GCP audits of investigator sites and/or CROs or comparable GxP audit experience is also required. Thorough knowledge of GxP systems, quality principles, and GCP/GVP regulations is essential.
The successful candidate will possess a strong attention to detail, ability to work independently and collaboratively, and experience with hosting GCP regulatory inspections. We offer a comprehensive benefits package, including incentive stock options, a 401K plan, and a flexible PTO policy.
Larimar Therapeutics is an equal-employment opportunity employer, committed to diversity and inclusion. We strive to create a workplace that is free from discrimination and harassment, and where all employees feel valued and respected.
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