Associate Director/Director, Quality Assurance

3 days ago

BalaCynwyd, Pennsylvania, United States Larimar Therapeutics Full time
Job Title: Associate Director/Director, Quality

Larimar Therapeutics Inc. is a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging its technology platform and applying its team's expertise to the development of nomlabofusp and other future pipeline projects.

Key Responsibilities:
  • Provide GCP/GVP Quality oversight, guidance, and support cross-functionally within Larimar.
  • Manage compliance and study-specific risk assessments and facilitate root cause analysis, CAPA implementation, and effectiveness checks regarding GCP/GVP operations.
  • Develop, implement, and execute the risk-based audit strategy for Clinical and Pharmacovigilance programs.
  • Oversee/lead the execution of external audits of GCP/GVP vendors and investigator sites and lead internal GCP/GVP audits.
  • Conduct Quality review of GCP/GVP-related documentation, including study protocols, study plans, ICFs, study reports, Investigator Brochure, Safety Management Plans, and other clinical trial specific documents and associated data.
  • Collaborate with Quality representatives at Larimar's CROs and service providers to ensure the appropriate Quality Agreements and study plans have been developed and implemented in support of Larimar's clinical studies.
  • Participate in relevant clinical and safety related team meetings.
  • Support the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools.
  • Assist in inspection readiness preparation and directly support regulatory agency inspection(s).
  • Support evaluation of new GCP/GVP related regulation and potential implications for Larimar.
  • Lead investigations for GCP or GVP issues including facilitating identification of root cause and development of appropriate corrective and preventive actions, tracking actions and confirming effectiveness, and ensuring reporting of potential or confirmed violations to regulatory authorities, as appropriate.
  • Support quality system monitoring reviews.
  • Assist in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested.
  • Support other Quality activities, as required.

Requirements:

A Bachelor's degree in life sciences with a minimum of 8+ years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment is required. A minimum of 2 years experience performing GCP audits of investigator sites and/or CROs or comparable GxP audit experience. Thorough knowledge of GxP systems, quality principles, and GCP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) and ability to translate understanding to practice is also required. Experience with hosting GCP regulatory inspections is preferred. The successful candidate will 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.

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