GCP Audit Manager / Senior Manager
NGM Biopharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
Opportunity to expand auditing expertise to clinical subcontractors’ evaluation and auditing.
- Performs clinical site audits to assess quality of clinical trials conducted by NGM.
- Ensures implementation and development of the strategies and procedures set up by Head of Quality Assurance.
- Performs clinical site audits to evaluate compliance with ICH GCP, local regulations and laws, study requirements, NGM SOPs, and applicable guidelines.
- Prepares audit reports.
- Oversees CAPA preparation, reviews CAPAs and follows-up with the CAPAs until resolution.
- Notifies Clinical QA of any significant QA discrepancies (fraud suspicion, etc.) which could affect a study, a project, or company operational integrity.
- BA/BS or equivalent degree in scientific discipline.
- Minimum of two (2- 5) years of documented experience in investigational site auditing in U.S. and/or Ex-U.S.
- Knowledge of ICH guidelines, FDA laws and guidelines in clinical research process (including basic understanding of GMP and GLP requirements needed on the site level for compliant and effective clinical study conduct).
- Excellent written and oral communication skills.
- Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and good working relationship with company personnel at all levels, with physicians, and with CROs.
- Ability to identify process gap and ability to provide alternative solutions to cover the process gaps (site level, Sponsor level).
- Ability to manage work schedule in accordance with priorities.
- Flexibility and willingness to work in a team environment.
- Preferred certified auditor (ASQ CQA, CCRP or similar).
- Available for frequent traveling when necessary, including overnight stays.
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, employee stock purchase program participation, 401(k) and a comprehensive, industry-leading, benefits package.
Interested applicants should click "Apply"
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