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:
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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