Director, Quality (GCP/GCLP/GVP)

Director, Quality (GCP/GCLP/GVP)

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:

• 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

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

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.