Development Quality Auditor

Development Quality Auditor

25 May 2024
Massachusetts, Cambridge, 02138 Cambridge USA

Development Quality Auditor

Vacancy expired!

Development Quality Auditor

Position Overview


We have an exciting 100% remote

Development Quality Auditor opportunity available in the Greater Boston area for a gene therapy, publicly traded Biotech company! The

Development Quality Auditor will be responsible for leading developmental strategies that align with global regulations for this growing organization.


Responsibilities


  • Oversee external auditor contracts, purchase orders, deliverables, and performance according to Vendor Oversight Plans

  • Conduct assessments for proposed external vendor relationships

  • Oversee, track and report metrics related to Development Vendor Oversight Plan

  • Conduct, report, and follow-up on internal and external audits

  • Ensure audit observations are communicated, tracked, stored, and remediated in compliance with internal policies and regulatory requirements

  • Ensure all Auditor's complete the Auditor Qualification Program and provide program training
  • Maintain the Approved Vendor List, and Development Internal and External Audit Schedules

  • Manage an efficient and effective risk-based audit and external vendor oversight program, escalating issues as needed

  • Report metrics from risk-based program oversight and triage Quality Tolerance Limits when exceeded within the Quality Management System

  • Monitor and report industry development inspection trends, new/revised regulations, and guidance for impact to operations
  • Support regulatory inspections as required



Requirements or Equivalent Experience


  • Strong knowledge of global regulations and practical application of


Google Cloud Platform and GcLP requirements through extensive auditing


  • 5+ years of experience in the industry, ideally non-clinical and early clinical phases

  • RQAP-Google Cloud Platform or other auditor certification preferred
  • Gene therapy experience a plus




If you are interested in working as a Development Quality Auditor and would like to learn more about this opportunity please send your updated resume to m.winn at realstaffing.com to discuss this position. (Referrals welcomed)




EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.


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