Associate Director/Director, Quality

4 weeks ago

Bala Cynwyd, United States Larimar Therapeutics Full time

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.


Job Responsibilities:

Position Overview:

The Assoc. Director/Director, Quality (GCP/GVP) will support the Quality organization at Larimar, leading Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)-related Quality activities related to clinical product development and clinical studies. This position will interact cross-functionally to provide GCP, GVP, and compliance support for ongoing and new clinical studies led by the Larimar Clinical Operations team. This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements and relevant global GCP regulations and guidelines. The Assoc. Director/Director, Quality (GCP/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:

  • 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.
  • Approximately 10-15% travel 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.


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.



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