NantHealth

Senior GCP Auditor


PayCompetitive
LocationMyrtle Point/Oregon
Employment typeFull-Time
  • Job Description

      Req#: R2746
      Employer Industry: Biotechnology

      Why consider this job opportunity:
      - Salary up to $153,000 annually for highly experienced candidates
      - Eligible for discretionary bonuses and equity awards
      - Flexible remote work environment with a supportive team
      - Comprehensive benefits package, including medical, dental, and vision options, unlimited PTO for exempt employees, and a 401(k) retirement plan with company match
      - Opportunities for professional development and growth within a publicly traded biopharmaceutical company
      - Engage in meaningful work that contributes to innovative cancer therapies and patient care

      What to Expect (Job Responsibilities):
      - Ensure compliance with GCP standards and maintain inspection readiness at all times
      - Conduct vendor/supplier audits, internal audits, compliance visits, and clinical trial site audits
      - Develop and review SOPs and other controlled documents to align with industry standards
      - Manage the incident management program, including monitoring complaints, deviations, and corrective actions
      - Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and other teams to resolve GCP compliance issues

      What is Required (Qualifications):
      - Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master’s degree with a minimum of 4 years of experience
      - Strong understanding and application of ICH GCP E6 (R2) regulations
      - Excellent problem-solving and analytical skills, with attention to detail
      - Proficient in both verbal and written communication
      - Ability to manage multiple projects and prioritize tasks effectively

      How to Stand Out (Preferred Qualifications):
      - CQA or other audit certifications
      - Experience with TMF or electronic document management systems
      - Demonstrated ability to work flexibly, including off-hours or weekends as needed

      #Biotechnology #ClinicalTrials #GCPCompliance #RemoteWork #CareerGrowth #HealthcareInnovation

      We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
      We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
  • About the company

      NantHealth, a member of the NantWorks ecosystem of companies, is a next-generation, evidence-based, personalized healthcare company enabling improved patient outcomes and more effective treatment decisions for critical illnesses. NantHealth‘s unique sy...

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