Associate Director/Director, Quality Assurance

12 hours ago

Bala Cynwyd, United States Larimar Therapeutics Full time
Job Title:

Associate Director/Director, Quality

Job Summary:

Larimar Therapeutics is seeking an experienced Associate Director/Director, Quality to join our team. The successful candidate will provide GCP/GVP Quality oversight, guidance, and support cross-functionally within Larimar.

Key Responsibilities:
  • Provides GCP/GVP Quality oversight, guidance, and support cross-functionally within Larimar.
  • Manages compliance and study-specific risk assessments and facilitates root cause analysis, CAPA implementation, and effectiveness checks regarding GCP/GVP operations.
  • Develops, implements, and executes the risk-based audit strategy for Clinical and Pharmacovigilance programs.
  • Oversees/leads the execution of external audits of GCP/GVP vendors and investigator sites and leads internal GCP/GVP audits.
  • Conduct Quality review of GCP/GVP-related documentation, including but not limited to: study protocols, study plans, ICFs, study reports, Investigator Brochure, Safety Management Plans, and other clinical trial specific documents and associated data.
  • Collaborates 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.
  • Participates in relevant clinical and safety related team meetings.
  • Supports the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools.
  • Assists in inspection readiness preparation and directly supports regulatory agency inspection(s).
  • Supports evaluation of new GCP/GVP related regulation and potential implications for Larimar.
  • Leads 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.
  • Supports 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:
  • Preferred Qualifications:
  • Title and compensation will be dependent on years of experience and qualifications.
  • This role requires 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.

Equal Employment Opportunity:

Larimar Therapeutics is committed to equal-employment principles and recognizes the value of committed employees who feel they are being treated in an equitable and professional manner.

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